Fexofenadine Use in Gastroesophageal Reflux Symptoms

Phase 2

Terminated

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.

Recruitment & Eligibility

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)

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Fexofenadine then Placebo	Placebo - Cap	Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
Placebo then Fexofenadine	Placebo - Cap	Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.
Fexofenadine then Placebo	Fexofenadine	Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
Placebo then Fexofenadine	Fexofenadine	Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.

Primary Outcome Measures

Name	Time	Method
Mean Symptom Severity Score	2 weeks per treatment	Severity of reflux symptoms on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe)
Mean Number of Reflux Episodes Per Day	2 weeks per treatment
Mean Rescue Medications Per Day	2 weeks per treatment	Medications such as Tums or Pepcid can be used if reflux symptoms are severe and relief is needed (additional doses of proton pump inhibitors are not allowed beyond the regular dosing)
Mean Percent of Days With Reflux	2 weeks per treatment
Mean GERD-HRQL Questionnaire Score	2 weeks per treatment	The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total.

Secondary Outcome Measures

Name	Time	Method
Patient Medication Preference	Will be assessed at the end of the trial (total trial time is 6 weeks)	Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine.
Count of Participants With Side Effects	Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks)	Patients will write down side effects at the end of each treatment period. If severe patients should seek medical attention immediately and report the side effects to us.