TerminatedPhase 2

Fexofenadine Use in Gastroesophageal Reflux Symptoms

Stopped: The study was terminated due to insufficient evidence for Fexofenadine efficacy to treat GERD symptoms after the interim analysis.

United States11 participantsStarted 2018-02-07

Plain-language summary

The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A minimum 6-month history of heartburn and regurgitation, as their main symptom * Experience at least 3-4 days with episodes of heartburn or regurgitation per week * Female patients who are postmenopausal or using acceptable methods of birth control. Exclusion Criteria (selected) * Esophageal stricture * Primary esophageal motility disorder * Systemic sclerosis * Active inflammatory bowel disease * Zollinger-Ellison syndrome * Active gastric or duodenal ulcer * Active infectious or inflammatory conditions of the small or large intestine * Malabsorption syndromes of the intestine * History of gastrointestinal cancer * Current active cancer * Prior gastric or intestinal surgery * Pregnant or breast feeding * Other serious psychiatric or medical disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Percent of Days With Reflux

Timeframe: 2 weeks per treatment

Mean Number of Reflux Episodes Per Day

Timeframe: 2 weeks per treatment

Mean GERD-HRQL Questionnaire Score

Timeframe: 2 weeks per treatment

Mean Symptom Severity Score

Timeframe: 2 weeks per treatment

Mean Rescue Medications Per Day

Timeframe: 2 weeks per treatment

Trial details

NCT IDNCT03425097

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-08

Results submitted2021-01-27

View on ClinicalTrials.gov More Gastroesophageal Reflux trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Percent of Days With Reflux

Timeframe: 2 weeks per treatment

Mean Number of Reflux Episodes Per Day

Timeframe: 2 weeks per treatment

Mean GERD-HRQL Questionnaire Score

Timeframe: 2 weeks per treatment

Mean Symptom Severity Score

Timeframe: 2 weeks per treatment

Mean Rescue Medications Per Day

Timeframe: 2 weeks per treatment