Fexofenadine Use in Gastroesophageal Reflux Symptoms

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Gastroesophageal Reflux

Treatments: Drug: Placebo - Cap; Drug: Fexofenadine

Study type: Interventional

Funder types: Other

Identifiers

NCT03425097

IRB-44650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Fexofenadine then Placebo

Experimental group

Description:

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

Treatment:

Drug: Fexofenadine

Drug: Placebo - Cap

Placebo then Fexofenadine

Experimental group

Description:

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

Treatment:

Drug: Fexofenadine

Drug: Placebo - Cap