Fexofenadine Use in Gastroesophageal Reflux Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: Fexofenadine
* Drug: Placebo - Cap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fexofenadine then Placebo<br>Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo. | Drug: Fexofenadine<br>* Fexofenadine 180 mg in the morning<br>Drug: Placebo - Cap<br>* Placebo cap in the morning<br>|
| Experimental: Placebo then Fexofenadine<br>Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine. | Drug: Fexofenadine<br>* Fexofenadine 180 mg in the morning<br>Drug: Placebo - Cap<br>* Placebo cap in the morning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of Days With Reflux |  | 2 weeks per treatment | 
| Mean Number of Reflux Episodes Per Day |  | 2 weeks per treatment | 
| Mean GERD-HRQL Questionnaire Score | 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. | 2 weeks per treatment | 
| Mean Symptom Severity Score | Severity of reflux symptoms on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe) | 2 weeks per treatment | 
| Mean Rescue Medications Per Day | 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) | 2 weeks per treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Medication Preference | Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine. | Will be assessed at the end of the trial (total trial time is 6 weeks) | 
| Count of Participants With Side Effects | 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. | Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks) |