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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
Fexofenadine 180 mg in the morning
Placebo cap in the morning
Stanford Health Care
Redwood City, California, United States
Mean Percent of Days With Reflux
Time frame: 2 weeks per treatment
Mean Number of Reflux Episodes Per Day
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 2 weeks per treatment
Patient Medication Preference
Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine.
Time frame: 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.
Time frame: Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks)
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