Fexofenadine Use in Gastroesophageal Reflux Symptoms

NCT ID: NCT03425097

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2019-01-08

Brief 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.

Detailed Description

Around 18-28% of North American adults have gastroesophageal reflux symptoms once per week. Of those patients up to 60% may have an inadequate response to proton pump inhibitors and have persistent symptoms. One possible explanation is that this group of patients has nerve related pain. It is thought that H1 receptor activation may sensitize the gastrointestinal tract and esophagus to pain. H1 blockers such as anti-histamines may play a role in treatment of gastroesophageal reflux symptoms that are refractory to proton pump inhibitors by reducing pain perception. The investigators wish to conduct a randomized control trial to test this hypothesis. 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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fexofenadine then Placebo

Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.

Group Type: EXPERIMENTAL

Fexofenadine

Intervention Type: DRUG

Fexofenadine 180 mg in the morning

Placebo - Cap

Intervention Type: DRUG

Placebo cap in the morning

Placebo then Fexofenadine

Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.

Group Type: EXPERIMENTAL

Fexofenadine

Intervention Type: DRUG

Fexofenadine 180 mg in the morning

Placebo - Cap

Intervention Type: DRUG

Placebo cap in the morning

Interventions

Fexofenadine

Fexofenadine 180 mg in the morning

Intervention Type: DRUG

Placebo - Cap

Placebo cap in the morning

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Zikos

Fellow in Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Health Care

Redwood City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-44650

Identifier Type: -

Identifier Source: org_study_id