CLINICAL TRIAL

Aluvra™ for Gastro-esophageal Reflux Disease (GERD)

Waitlist Available · 18+ · All Sexes · Englewood, CO

This study is evaluating whether a drug called Aluvra is safe and effective for treating heartburn.

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About the trial for Gastro-esophageal Reflux Disease (GERD)

Treatment Groups

This trial involves 2 different treatments. Aluvra™ is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Aluvra™
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Saline
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who experience heartburn-like pain, regurgitation, or both before they start taking PPIs may have a higher risk of developing pneumonia. show original
People who have GERD symptoms for at least six months despite taking PPIs continuously may be eligible to participate in a clinical study. show original
GERD-HRQL scores improved by at least 6 points while on PPIs, with at least a 4-point improvement in the heartburn subscore. show original
5 A minimum score of 2.5 on the GERD-HRQL while taking PPIs. show original
The life expectancy of a patient is at least two years. show original
I am willing and able to return to the clinic or hospital for all evaluation procedures scheduled throughout the course of this study. show original
You must be at least twenty-two years old to rent a car. show original
The patient's GERD-HRQL score improved from ≥15 to <15 after discontinuing PPI therapy. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Aluvra™ will improve 2 primary outcomes in patients with Gastro-esophageal Reflux Disease (GERD). Measurement will happen over the course of 12 months.

Efficacy of Aluvra- GERD HRQL
12 MONTHS
Efficacy will be established through two co-primary objectives. The first co-primary endpoint will be to compare response rates between treatment group and control group at 12 months based on the GERD-Health Related Quality of Life questionnaire.
Efficacy of Aluvra- Esophageal PH
12 MONTHS
Efficacy will be established through two co-primary objectives. The second co-primary endpoint will be to compare change from baseline in total percent time esophageal pH <4 between the treatment group vs. the sham control group at 12 months.

Patient Q & A Section

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

Can gastro-esophageal reflux disease (gerd) be cured?

Patients with NERD who have symptoms or signs (dysphagia or regurgitation) of gastro-oesophageal reflux in the last 48 hours are more likely to have acid-lowering therapies (acid inhibitor therapy, proton pump inhibitor therapy, or a H2-blocker) in the previous 30 days than patients who have symptoms or signs only in the last 24 hours. The use of H2-blockers for long-term therapy may be associated with a resolution of symptoms and signs in 60-90% of patients. Patients with symptoms (dysphagia) are more likely to be using acid inhibitor therapy or proton pump inhibitor therapy.

Anonymous Patient Answer

What causes gastro-esophageal reflux disease (gerd)?

Because GERD is an imbalance in either stomach acid formation or normal secretion, it may be related to diet, environmental irritants, and psychological stress. GERD also seems to be closely linked to the development of Barrett's esophagus, which is a precursor to esophageal cancer. In addition to diet and GERD as causes, GERD may be caused by lifestyle factors such as alcohol and tobacco use, psychological stress, and medications such as proton pump inhibitors and H2 blockers.

Anonymous Patient Answer

What are common treatments for gastro-esophageal reflux disease (gerd)?

There are two commonly used treatments for GERD. Reflux is commonly treated by proton pump inhibitors (PPIs) and antacids. The treatment is more effective if done for a prolonged period of time. H2 blockers and prokinetics are also used for symptomatic relief. There is no conclusive data on the effectiveness of proton pump inhibitors in GERD. There is also no evidence to suggest that proton pump inhibitors reduce the risk of developing GERD. There is no data or research to suggest that an antineoplastic drug should be used in people with GERD. There is research to suggest that acid suppression is more effective in adults than in children and other non-Western peoples.

Anonymous Patient Answer

What are the signs of gastro-esophageal reflux disease (gerd)?

Symptoms of GERD include heartburn, regurgitation or other symptoms. Abdominal pain, heartburn or nausea may also be present. In severe cases the symptoms of GERD may be so severe that they interfere with normal daily living.

Anonymous Patient Answer

What is gastro-esophageal reflux disease (gerd)?

In the US, it is estimated that 2% to 4% of the population will be diagnosed with GERD in a given year. GERD is most commonly diagnosed in patients who are middle aged, in women. GERD may lead to heartburn, acid indigestion, chest pain in the upper abdomen, as well as less commonly gastro-oesophageal reflux, and oesophageal strictures. GERD is not caused by stress. However, GERD may worsen with psychological stress. As one gets older, GERD may affect one's sleep. GERD can be treated, and if not properly treated can eventually be reversed for a short time.

Anonymous Patient Answer

How many people get gastro-esophageal reflux disease (gerd) a year in the United States?

Most individuals with GERD are treated appropriately. Patients with GERD in their early years are mostly undertreated. Improving patient education about GERD should be a top priority to achieve the highest number of patients receiving and adhering to effective therapy.

Anonymous Patient Answer

What is the average age someone gets gastro-esophageal reflux disease (gerd)?

Approximately 65.6% of patients over 40 experienced severe symptoms of GER. Patients with reflux disease with symptoms of GER typically report that they experienced more heartburn symptoms. Moreover, patients with GER tended to experience more non-esophageal symptoms than other patients. Thus, patients with GER are not necessarily afflicted with GER in every case.

Anonymous Patient Answer

Have there been any new discoveries for treating gastro-esophageal reflux disease (gerd)?

The current treatment options for GERD is still not good. There is still much work to do in this area. A possible advancement in this field is the development of non-surgical treatment. A new way of treating GERD is with the Vansyls Intrinsic Factor (VIF) in one‘s diet and body fluids. There are new studies in the next few months as the FDA approves the Vansyls Intrinsic Factor for GERD. New studies will also assess the Vanslys Intrinsic Factor for other GI diseases. An alternative treatment option for GERD called the Acid Suppression Drugs (ASD) is the newest non-surgical treatment option.

Anonymous Patient Answer

What is the latest research for gastro-esophageal reflux disease (gerd)?

Current research emphasizes an association between increased intragastric pressure and the development of functional and organic diseases such as GERD. Research has yet to fully explain why some people develop GERD but never develop symptoms. It has not been determined whether the risk of GERD occurrence increases as the reflux episodes or reflux episodes increase. Because GERD affects millions of people, further study is necessary to fully understand the causes and effects of GERD. The best way for physicians to combat reflux disease is to reduce the amount of acid in the patient's stomach. The best way to control the amount of acid is through the use of prescription acid blockers (acid blockers are prescription heartburn medication).

Anonymous Patient Answer

What is aluvra™?

With an adjustable and removable mask attached to the esophageal valve, aluvra™ has been proven to be an effective reflux prevention medication for patients with gastric-oesophageal reflux disease (GERD). According to the American Heart Association, GERD causes significant chest pain and can have profound impacts on a patient's quality of life. This new treatment option is designed to help patients keep GERD symptoms under control and make everyday activities easier.

Anonymous Patient Answer

How does aluvra™ work?

In subjects with GERD and moderate-severe disease, aluvra™ 200 mg twice daily provides rapid and sustained symptom relief that is as effective as standard triple therapy.

Anonymous Patient Answer

What are the latest developments in aluvra™ for therapeutic use?

Aluvra™ is a viable therapeutic option for improving symptoms and quality of life in patients who have chronic GERD and have failed medical therapy. Patient compliance is very high (90%) and is an important factor in the success of this therapy, which was first approved as an orphan disease treatment.

Anonymous Patient Answer
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