Fexofenadine Use in Gastroesophageal Reflux Symptoms

• Status: Terminated
• Trial end date: 2019-01-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Fexofenadine; Terfenadine

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