Pantoprazole for Nausea and Vomiting

Overseen By Casey Timmerman, DO

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: United States Naval Medical Center, Portsmouth

Must not be taking: H2 blockers, Proton pump inhibitors

Disqualifiers: Pregnant, Gastrointestinal disease, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pantoprazole, a medication typically used for heartburn, can reduce nausea and vomiting after gynecologic surgery. Participants will receive either the actual medication or a placebo (a pill with no active drug) around the time of their surgery. Women undergoing elective gynecological surgery under general anesthesia might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using H2 receptor blockers, proton pump inhibitors, or other GERD-specific therapies, you cannot participate in the trial.

Is there any evidence suggesting that pantoprazole is likely to be safe for humans?

Research has shown that pantoprazole is generally safe to use. Various studies report common side effects such as headache, diarrhea, nausea, and stomach pain, which are usually mild and manageable for most people.

Pantoprazole is approved for treating acid reflux and heartburn, indicating it is generally well-tolerated. No serious safety concerns have been reported when used for these conditions. However, some individuals have experienced mild skin rashes and joint pain. Awareness of these possible side effects is important, though they are uncommon and typically not serious.

Overall, pantoprazole is widely used and considered safe for many people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for nausea and vomiting, especially around surgeries, focus on blocking histamine or serotonin receptors. But pantoprazole works differently, as it is a proton pump inhibitor that reduces stomach acid production. By targeting acid production, pantoprazole might offer relief from nausea and vomiting related to acid reflux, which isn't the focus of traditional antiemetic drugs. Researchers are excited about pantoprazole because it could provide a new option for patients who don't respond well to standard treatments.

What evidence suggests that pantoprazole might be an effective treatment for nausea and vomiting after gynecologic surgery?

Research has shown that pantoprazole, which participants in this trial may receive, might help reduce nausea. One study effectively lessened delayed nausea in patients undergoing chemotherapy, suggesting it could also alleviate nausea after surgery. Although pantoprazole is typically used for acid reflux, it has shown promise in managing nausea, making it worth exploring for post-surgery symptoms. Participants in this trial will receive either pantoprazole or a placebo to evaluate its effectiveness in this context. ^{6 7 8 9 10}

Who Is on the Research Team?

Casey Timmerman, DO

Principal Investigator

United States Naval Medical Center, Portsmouth

Are You a Good Fit for This Trial?

This trial is for women aged 18-79 undergoing gynecologic surgery, aiming to see if pantoprazole can prevent postoperative nausea and vomiting. Specific eligibility criteria are not provided.

Inclusion Criteria

I am scheduled for gynecological surgery under general anesthesia.

Exclusion Criteria

I have had gastrointestinal surgery, but only for diagnosis, appendix removal, or gallbladder removal.

Lactose intolerance

I am receiving treatment for a gastrointestinal condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take three pills around their surgery: two before and one after, comparing pantoprazole to placebo

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of postoperative nausea and vomiting

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pantoprazole

Trial Overview The study tests whether pantoprazole, an acid reflux medication, is better than a placebo at preventing nausea and vomiting after surgery. Participants will take three pills around their operation time.

How Is the Trial Designed?

Group I: Active Active Control 1 Intervention

This arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

Group II: Placebo Placebo Group 1 Intervention

This arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

Pantoprazole is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Protonix for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in European Union as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome
• Peptic ulcer disease

Approved in Canada as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in Japan as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in China as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in Switzerland as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Who Is Running the Clinical Trial?

United States Naval Medical Center, Portsmouth

Lead Sponsor

Trials

35

Recruited

4,900+

Published Research Related to This Trial

Pantoprazole effectively inhibits gastric acid secretion by targeting the H(+)/K(+)-ATPase enzyme, with a favorable activation profile at lower pH levels compared to other proton pump inhibitors, making it a potent option for acid-related disorders.

Unlike omeprazole, pantoprazole has a lower potential for drug interactions due to its unique metabolic pathway, which may enhance its safety profile in patients taking multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic aspects of selectivity of pantoprazole and its pharmacological actions. Beil, W., Sewing, KF., Kromer, W.[2019]

70-80% of cancer patients undergoing chemotherapy experience nausea and vomiting, which can severely impact their quality of life and adherence to treatment.

Newer antiemetic agents like palonosetron and aprepitant provide additional benefits in managing delayed nausea and vomiting, particularly in patients receiving highly and moderately emetogenic chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Croatian guideliness for prevention of chemotherapy induced nausea and vomiting]. Tomek, R., Vrdoljak, E., Vrbanec, D., et al.[2009]

Effective management of nausea and vomiting in cancer patients, particularly from chemotherapy, relies on a guideline-directed combination of antiemetic medications, including 5HT3 receptor antagonists, NK1 receptor antagonists, and dexamethasone.

Recent advancements in antiemetic therapy include new drugs like palonosetron, rolapitant, and the combined drug NEPA, which enhance the prevention of chemotherapy-induced nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the Art Antiemetic Therapy for Cancer Patients. Lau, TK., Yip, CH., Yeo, W.[2018]

A survey of pediatric oncologists revealed that antiemetics are used 17%, 79%, and 98% of the time for chemotherapy agents associated with mild, moderate, and severe nausea and vomiting, respectively, indicating a strong reliance on antiemetic therapy based on the severity of symptoms.

The choice of antiemetics is primarily influenced by oncologists' personal experiences rather than current literature, which suggests that existing practices may not always align with the best available evidence for managing chemotherapy-induced nausea and vomiting in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of antiemetic use in children with cancer. van Hoff, J., Hockenberry-Eaton, MJ., Patterson, K., et al.[2015]

Aprepitant, a neurokinin (NK1) receptor antagonist, is the first drug shown to effectively prevent both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV), marking a significant advancement in antiemetic therapy.

Current guidelines recommend using aprepitant for patients undergoing highly and moderately emetogenic chemotherapy, although it is only reimbursed in Hungary after other antiemetic treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of tumor therapy-induced nausea and vomiting]. Pikó, B., Bassam, A.[2022]

Omeprazole, a proton pump inhibitor used since 1989 for treating peptic ulcers and other conditions, has been found to be well tolerated in most clinical trials, with adverse effects occurring in approximately 1 in 12,200 treatments over 4 weeks.

While the drug is generally safe, some reported adverse reactions include neurological issues like confusion (especially in older patients or those with liver disease), skin rashes, and potential hematological effects, prompting health authorities to inform prescribers about these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months]. Castot, A., Bidault, I., Dahan, R., et al.[2013]

Hepatotoxicity from proton pump inhibitors (PPIs) like pantoprazole is very rare, but it can occur, as demonstrated in a case involving a 35-year-old man treated for acute gastritis.

The patient's liver function improved one week after stopping pantoprazole, indicating that while hepatotoxicity is infrequent, discontinuation of the drug can lead to full recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver hepatotoxicity associated with pantoprazole: a rare case report. Aslan, M., Celik, Y., Karadas, S., et al.[2021]

In a double-blind study involving 208 patients, pantoprazole (40 mg daily) was found to be as effective as omeprazole (20 mg daily) in healing reflux esophagitis after 4 and 8 weeks, with healing rates of 94.2% for pantoprazole and 91.4% for omeprazole.

Both medications provided rapid relief from symptoms like heartburn and pain on swallowing, and were well tolerated, with very few adverse events leading to treatment withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicentre study. Corinaldesi, R., Valentini, M., Belaïche, J., et al.[2019]

In a study involving 202 outpatients, pantoprazole (40 mg) demonstrated a significantly higher healing rate for acute duodenal ulcers compared to ranitidine (300 mg), with 81% healing after 2 weeks versus 53% for ranitidine (P < 0.001).

After 4 weeks, pantoprazole continued to show superior efficacy with a healing rate of 97% compared to 83% for ranitidine (P < 0.01), and both treatments were well tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of pantoprazole and ranitidine in the treatment of acute duodenal ulcer. Pantoprazole-Duodenal Ulcer-Study Group. Judmaier, G., Koelz, HR.[2019]

Current pediatric guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) in children primarily recommend a serotonin 5-HT(3) receptor antagonist combined with a corticosteroid, but lack robust evidence and do not include many effective agents used in adults.

The review highlights the need for alternative antiemetic options for children who cannot tolerate or do not respond to standard treatments, discussing both established and emerging therapies like metopimazine, nabilone, and acupuncture, which may offer additional relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing emetic control in children receiving antineoplastic therapy: beyond the guidelines. Dupuis, LL., Nathan, PC.[2021]

Pantoprazole is an effective proton pump inhibitor used to treat various acid-related conditions, including gastroesophageal reflux disease and peptic ulcer disease, and has been safely used for over 13 years in more than 100 countries.

It has a strong safety profile with low risk for drug interactions, making it suitable for patients across all age groups, although it is officially indicated only for adults and adolescents in Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole: a proton pump inhibitor with oral and intravenous formulations. Devault, KR.[2018]

In a study of 286 patients with reflux oesophagitis, both pantoprazole (40 mg) and omeprazole (20 mg) demonstrated similar healing rates after 4 weeks (74% vs. 78%) and 8 weeks (90% vs. 94%), indicating comparable efficacy in treating the condition.

Both medications were well tolerated by patients, suggesting that they are safe options for treating mild to moderate reflux oesophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind study of pantoprazole and omeprazole in the treatment of reflux oesophagitis: a multicentre trial. Mössner, J., Hölscher, AH., Herz, R., et al.[2019]

In a study of 219 patients with benign gastric ulcers, pantoprazole (40 mg) demonstrated a higher healing rate after 4 weeks (88%) compared to omeprazole (77%), indicating its efficacy as a treatment.

Both pantoprazole and omeprazole were found to be equally safe, with only 10% of patients in each group reporting adverse events, suggesting that pantoprazole is a well-tolerated option for treating gastric ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole versus omeprazole in the treatment of acute gastric ulcers. Witzel, L., Gütz, H., Hüttemann, W., et al.[2019]

In a study of 209 patients with mild gastro-oesophageal reflux disease (GERD), low-dose pantoprazole (20 mg) provided significantly faster relief from symptoms compared to ranitidine (300 mg), with 69% of patients reporting complete relief after 2 weeks versus 48% for ranitidine.

Pantoprazole also demonstrated superior healing of GERD lesions, with 80% of patients showing healing after 4 weeks compared to 64% in the ranitidine group, indicating its greater efficacy in treating mild GERD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Dettmer, A., Vogt, R., Sielaff, F., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5894447/

Meta-analysis of the efficacy and safety of pantoprazole in the ... The most common adverse reactions were constipation (5 patients, 2%), nausea (4 patients, 1.6%), flatulence (3 patients, 1.2%), hypersensitivity (3 patients, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40394328/

Proton pump inhibition to prevent delayed chemotherapy ... Conclusions: Pantoprazole is a cost-effective and safe agent, which reduces rates of delayed nausea and should be considered as prophylaxis in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00829738

Study Details | NCT00829738 | Efficacy of Pantoprazole 20 ... The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related ...

4. withpower.com withpower.com/trial/phase-2-vomiting-7-2022-bcd69

Pantoprazole for Nausea and Vomiting In a study of 286 patients with reflux oesophagitis, both pantoprazole (40 mg) and omeprazole (20 mg) demonstrated similar healing rates after 4 weeks (74% vs.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jgh3.12988

Efficacy and safety of pantoprazole and itopride in patients ... Conclusion. The FDC of pantoprazole and itopride showed favorable efficacy and safety in patients with GERD and overlapping dyspepsia ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/pantoprazole-oral-route/description/drg-20071434

Pantoprazole (oral route) - Side effects & dosage ... nausea or vomiting, or unusual tiredness or weakness. Pantoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more ...

7. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/PZ01408.pdf

MATERIAL SAFETY DATA SHEET Known Clinical Effects: Adverse effects most commonly reported in clinical use include headache, diarrhea, nausea, and flatulence. May cause mild skin rash.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf

WARNINGS AND PRECAUTIONS - accessdata.fda.gov Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral PROTONIX (20 mg or 40 mg), 299 patients on an H2- ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499945/

Pantoprazole - StatPearls - NCBI Bookshelf In both inpatient and outpatient settings, pantoprazole remains a common therapeutic agent due to a favorable safety profile and availability ...

10. webmd.com webmd.com/drugs/2/drug-17633/pantoprazole-oral/details

Pantoprazole (Protonix) - Uses, Side Effects, and More What are the most common side effects of pantoprazole? · Headache · Diarrhea · Nausea · Stomach pain · Vomiting · Gas · Dizziness · Joint pain ...