Pantoprazole Sodium

Curling Ulcer, Zollinger-Ellison Syndrome, Heartburn + 14 more
Treatment
17 FDA approvals
20 Active Studies for Pantoprazole Sodium

What is Pantoprazole Sodium

PantoprazoleThe Generic name of this drug
Treatment SummaryPantoprazole is a medication used to reduce the amount of stomach acid produced. It is used to treat gastroesophageal reflux disease (GERD), peptic ulcer disease, and other conditions caused by too much stomach acid. It can also be used in combination with other antibiotics to treat infections caused by _H. pylori_. Pantoprazole works by blocking an enzyme that is necessary for acid production in the stomach. Its effects last longer than 24 hours, making it a popular choice for long-term treatment. While it is generally safe and effective, there are some potential side effects associated with long-
Protonix Delayed-releaseis the brand name
image of different drug pills on a surface
Pantoprazole Sodium Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Protonix Delayed-release
Pantoprazole
2000
353

Approved as Treatment by the FDA

Pantoprazole, also called Protonix Delayed-release, is approved by the FDA for 17 uses like Gastric Ulcer and Zollinger-Ellison Syndrome .
Gastric Ulcer
Zollinger-Ellison Syndrome
Helps manage Zollinger-Ellison Syndrome
Gastro-esophageal Reflux Disease (GERD)
Erosive Esophagitis
pathological hypersecretory conditions
Duodenal Ulcer
GERD With Erosive Esophagitis
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Reflux Esophagitis (RE)
conditions where a reduction of gastric acid secretion is required
Healing
Heartburn
Pathological Conditions, Anatomical
Curling Ulcer
Stomach Ulcer
Gastroesophageal Reflux
Gastroesophageal reflux disease

Effectiveness

How Pantoprazole Sodium Affects PatientsPantoprazole reduces the amount of acid in the stomach, and can help relieve symptoms of acid reflux, heal inflammation of the esophagus, and improve patient quality of life. It is generally considered safe and has few drug interactions. However, long-term use of PPIs such as pantoprazole may be linked to increased risk of bacterial infections, reduced absorption of nutrients, and increased risk of bone fractures. It has also been linked to an increased risk of cardiovascular events due to its effect on an enzyme called DDAH. Before taking measurements of chromogranin A or urine screening tests for THC, pantop
How Pantoprazole Sodium works in the bodyHydrochloric acid is a normal part of the stomach, and is formed by a proton pump enzyme in the parietal cells of the stomach. Pantoprazole is a type of proton pump inhibitor, which works by binding to the enzyme and making it unable to create hydrochloric acid. This blocks the formation of hydrochloric acid and stops it from being released into the stomach, reducing acid levels in the stomach and providing relief for conditions such as heartburn.

When to interrupt dosage

The portion of Pantoprazole Sodium is contingent upon the recognized affliction, including Gastric Ulcer, Healing and Heartburn. The degree of dosage can be found in the table below, dependent on the method of administration.
Condition
Dosage
Administration
Stomach Ulcer
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Heartburn
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Curling Ulcer
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Zollinger-Ellison Syndrome
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Pathological Conditions, Anatomical
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Helicobacter Pylori Infection
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Gastroesophageal Reflux
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Erosive Esophagitis
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Critical Illness
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Gastroesophageal reflux disease
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Reflux Esophagitis (RE)
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
patients who are unable to continue taking pantoprazole delayed-release tablets
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
prophylaxis of Stress Ulcers
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Stress Ulcers
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Heartburn
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
conditions where a reduction of gastric acid secretion is required
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution
Healing
, 4.0 mg/mL, 40.0 mg, 20.0 mg
Granule, delayed release, Granule, delayed release - Oral, Intravenous, Injection, powder, for solution, , Injection, powder, for solution - Intravenous, Tablet, delayed release, Tablet, delayed release - Oral, Oral, Tablet, Tablet - Oral, Powder, for solution, Powder, for solution - Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Injection, powder, lyophilized, for solution

Warnings

Pantoprazole Sodium Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
HIV Positive
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Pantoprazole may interact with Pulse Frequency
Severe Hypersensitivity Reactions
Do Not Combine
Pantoprazole may interact with Pulse Frequency
There are 20 known major drug interactions with Pantoprazole Sodium.
Common Pantoprazole Sodium Drug Interactions
Drug Name
Risk Level
Description
Acenocoumarol
Major
The metabolism of Acenocoumarol can be decreased when combined with Pantoprazole.
Atazanavir
Major
The therapeutic efficacy of Atazanavir can be decreased when used in combination with Pantoprazole.
Axitinib
Major
The metabolism of Axitinib can be decreased when combined with Pantoprazole.
Cyclophosphamide
Major
The metabolism of Cyclophosphamide can be decreased when combined with Pantoprazole.
Infigratinib
Major
The serum concentration of Infigratinib can be decreased when it is combined with Pantoprazole.
Pantoprazole Sodium Toxicity & Overdose RiskIn animal studies, pantoprazole was found to be toxic at a dose of 747mg/kg for rats. Long-term studies in rodents have shown that pantoprazole may lead to rare types of stomach tumors, but it is unknown if this is relevant to humans. This drug is considered safe for pregnant women, but it is still advised to only use it when absolutely necessary. Pantoprazole has been found in breast milk from one nursing mother after a single 40mg dose, but it is not known what the effects could be on nursing infants.
image of a doctor in a lab doing drug, clinical research

Pantoprazole Sodium Novel Uses: Which Conditions Have a Clinical Trial Featuring Pantoprazole Sodium?

23 active studies are currently being conducted to assess the efficacy of Pantoprazole Sodium in relieving Gastric Ulcers, Critical Illness and Stress Ulcers.
Condition
Clinical Trials
Trial Phases
conditions where a reduction of gastric acid secretion is required
0 Actively Recruiting
Zollinger-Ellison Syndrome
0 Actively Recruiting
Heartburn
2 Actively Recruiting
Phase 3, Not Applicable
Gastroesophageal reflux disease
0 Actively Recruiting
Curling Ulcer
0 Actively Recruiting
Heartburn
12 Actively Recruiting
Phase 3, Phase 2, Not Applicable
Helicobacter Pylori Infection
2 Actively Recruiting
Not Applicable, Phase 4
Healing
0 Actively Recruiting
Erosive Esophagitis
2 Actively Recruiting
Phase 2, Phase 3
patients who are unable to continue taking pantoprazole delayed-release tablets
0 Actively Recruiting
Pathological Conditions, Anatomical
3 Actively Recruiting
Phase 3, Not Applicable, Phase 2
Reflux Esophagitis (RE)
0 Actively Recruiting
Critical Illness
0 Actively Recruiting
Stress Ulcers
0 Actively Recruiting
Gastroesophageal Reflux
0 Actively Recruiting
Stomach Ulcer
2 Actively Recruiting
Phase 4, Not Applicable
prophylaxis of Stress Ulcers
0 Actively Recruiting

Pantoprazole Sodium Reviews: What are patients saying about Pantoprazole Sodium?

5Patient Review
3/7/2022
Pantoprazole Sodium for Medication Treatment for Healing Erosive Esophagitis
I've been on Pantoprazole 20mg for close to two years now, and it's been amazing. I can eat whatever I want without experiencing any acid reflux! The only side effect is occasionally insomnia, but that's tolerable.
5Patient Review
4/23/2022
Pantoprazole Sodium for Condition in which Stomach Acid is Pushed Into the Esophagus
I've only been on this medication for a short time, but it has already made a huge difference for me. I would highly recommend it to anyone suffering from acid reflux or heartburn.
5Patient Review
2/7/2022
Pantoprazole Sodium for Inflammation of the Esophagus with Erosion
I've been taking Pantoprazole 20mg 2x daily for a little over a year now and it's done wonders for my eroded esophagus and GERD.
5Patient Review
6/8/2022
Pantoprazole Sodium for Increased Stomach Acid from Systemic Mastocytosis
I've been on this medication for nearly 2 years and have not had a single instance of heartburn. Love it!
4.3Patient Review
9/25/2022
Pantoprazole Sodium for Condition in which Stomach Acid is Pushed Into the Esophagus
I started gaining weight at a rate of 3-4 pounds per month. In the span of five months, I went from 220 to 255 pounds.
3.7Patient Review
4/7/2022
Pantoprazole Sodium for Condition in which Stomach Acid is Pushed Into the Esophagus
Pantoprazole was great for my stomach acid problems, but I unfortunately had to stop taking it after learning that it caused a kidney stone.
3Patient Review
4/11/2022
Pantoprazole Sodium for Heartburn
I have never had such negative reactions to a medication before. This caused me immense stomach pain, joint pain, anxiety, depression, brain fog, and made it difficult to concentrate or even stand up without feeling lightheaded.
2Patient Review
7/20/2022
Pantoprazole Sodium for Increased Stomach Acid from Systemic Mastocytosis
Do not bother with this treatment. It might help your stomach, but it gave me such severe anxiety that I felt like I was going crazy. I took it for eight weeks and the feeling only got worse. Finally, I stopped taking it on my own and switched to Zantac--which helped within a few weeks.
1.7Patient Review
8/8/2022
Pantoprazole Sodium for Excessive Production of Stomach Acid
I had much better luck with my reflux before taking this drug. My doctor wanted me to use it as a preventative measure, but unfortunately it made things much worse for me. I stopped taking it after a week and I'm still dealing with throat pain from the acid - almost a month later. Please be careful before you decide to take this medication.
1.7Patient Review
9/6/2022
Pantoprazole Sodium for Condition in which Stomach Acid is Pushed Into the Esophagus
I developed a heart condition after taking this medication for an extended period of time. I'm not sure if the two are related, but it's something to be aware of.
1.7Patient Review
10/30/2022
Pantoprazole Sodium for Inflammation of the Esophagus with Erosion
I found this medicine to be incredibly irritating. It got to the point where I thought it was making me lose my mind. Not only that, but the anxiety from thinking I was losing my mind made my GERD so much worse. This "medicine" came close to driving me to suicide.
1Patient Review
11/18/2021
Pantoprazole Sodium for Increased Stomach Acid from Systemic Mastocytosis
I tried one 40mg tablet and it felt like I had been poisoned. I saw things that weren't there and felt terrible overall. Please remove this product from the market before it hurts anyone else.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about pantoprazole sodium

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is pantoprazole sodium used for?

"Pantoprazole cuts down on the amount of stomach acid produced. It can be used for heartburn, acid reflux, and gastroesophageal reflux disease (GERD). GERD is a condition where acid reflux occurs frequently. Pantoprazole is also taken to prevent and treat stomach ulcers."

Answered by AI

What are the side effects of pantoprazole sodium?

"The following are symptoms of uncontrolled diabetes: blurred vision, flushed skin, dry mouth, fruit-like breath odor, increased hunger, increased thirst, increased urination, stomach pain, and trouble breathing. If you experience any of these symptoms, please contact your doctor."

Answered by AI

What is pantoprazole sodium 40mg?

"Pantoprazole is used to treat certain stomach and esophagus problems, such as acid reflux. It works by decreasing the amount of acid your stomach makes, which relieves symptoms such as heartburn, difficulty swallowing, and persistent cough."

Answered by AI

What is the best time to take pantoprazole?

"It is typically recommended to take pantoprazole once daily, either before breakfast or 30-60 minutes before a meal. If taking the medication twice daily, take the first dose before breakfast and the second dose before dinner. Swallow the tablets whole; do not split, crush, or chew them."

Answered by AI

Clinical Trials for Pantoprazole Sodium

Image of University of California, Irvine - UCI Medical Center in Orange, United States.

Sling-Fiber Preservation vs. Conventional POEM for Achalasia

18+
All Sexes
Orange, CA
Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.
Waitlist Available
Has No Placebo
University of California, Irvine - UCI Medical CenterJason Samarasena, MD, MBA
Image of Johns Hopkins Hospital in Baltimore, United States.

Fetoscopic Endoluminal Tracheal Occlusion for Congenital Diaphragmatic Hernia

18+
Female
Baltimore, MD
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH \< 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR \< 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR \< 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR \<30% when compared to isolated LCDH with o/e LRH \<30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR \< 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Recruiting
Has No Placebo
Johns Hopkins HospitalAhmet Baschat, MDKARL STORZ Endoscopy-America, Inc.
Have you considered Pantoprazole Sodium clinical trials? We made a collection of clinical trials featuring Pantoprazole Sodium, we think they might fit your search criteria.Go to Trials
Image of Medical College of Wisconsin in Milwaukee, United States.

Fosamprenavir + Sodium Alginate for GERD

18 - 64
All Sexes
Milwaukee, WI
The goal of this clinical trial is to learn if study drug Fosamprenavir-Sodium Alginate (FOS-SA) administered orally improves symptoms for Proton Pump Inhibitor (PPI)-refractory Gastro Esophageal Reflux Disease (GERD). The main questions it aims to answer are: 1. Does FOS-SA significantly improve heartburn severity over the 8-week treatment period 2. Does FOS-SA significantly improve regurgitation frequency over the 8-week treatment period 3. Does FOS-SA significantly improve symptoms of persistent GERD over the 8-week treatment period Researchers will compare FOS-SA to a placebo (a look-alike substance that contains no active drug) to see if FOS-SA works to treat PPI-refractory GERD. Participants will: 1. Take FOS-SA or placebo every day BID (twice a day) for 8 weeks 2. Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests 3. Keep a daily diary of their symptoms of persistent GERD
Phase 2
Waitlist Available
Medical College of WisconsinNikki Johnston, PhD.
Image of Brigham and Women's Hospital in Boston, United States.

Low Thermal Plasma for Marginal Ulcers

18+
All Sexes
Boston, MA
The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.
Recruiting
Has No Placebo
Brigham and Women's HospitalChristopher C. Thompson, MD, MSc
Image of Brigham and Women's Hospital in Boston, United States.

Argon Plasma for Helicobacter Pylori Infection

18+
All Sexes
Boston, MA
The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible. Two different PAL generation modalities will be compared in this study: 1. HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach. 2. Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope. To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test. After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated. This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.
Recruiting
Has No Placebo
Brigham and Women's HospitalChristopher C Thompson, MDErbe Elektromedizin GmbH
Have you considered Pantoprazole Sodium clinical trials? We made a collection of clinical trials featuring Pantoprazole Sodium, we think they might fit your search criteria.Go to Trials
Image of Cleveland Clinic Center for Abdominal Core Health in Cleveland, United States.

Mesh vs Pledgets for Hernia Repair

18+
All Sexes
Cleveland, OH
The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. * Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms
Recruiting
Has No Placebo
Cleveland Clinic Center for Abdominal Core HealthDavid M Krpata, MD
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