Clinical trial NCT03425097: Fexofenadine Use in Gastroesophageal Reflux Symptoms
Official title: A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroesophageal Reflux
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean Percent of Days With Reflux
timeFrame: 2 weeks per treatment
measure: Mean Number of Reflux Episodes Per Day
timeFrame: 2 weeks per treatment
measure: Mean GERD-HRQL Questionnaire Score
timeFrame: 2 weeks per treatment
measure: Mean Symptom Severity Score
timeFrame: 2 weeks per treatment
measure: Mean Rescue Medications Per Day
timeFrame: 2 weeks per treatment
Secondary outcomes:
measure: Patient Medication Preference
timeFrame: Will be assessed at the end of the trial (total trial time is 6 weeks)
measure: Count of Participants With Side Effects
timeFrame: Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
References: