Fexofenadine Use in Gastroesophageal Reflux Disease

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.

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