Fexofenadine Use in Gastroesophageal Reflux Symptoms
Primary Purpose
Gastroesophageal Reflux
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fexofenadine
Placebo - Cap
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
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
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fexofenadine then Placebo
Placebo then Fexofenadine
Arm Description
Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.
Outcomes
Primary Outcome Measures
Mean Percent of Days With Reflux
Mean Number of Reflux Episodes Per Day
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.
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)
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)
Secondary Outcome Measures
Patient Medication Preference
Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03425097
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to insufficient evidence for Fexofenadine efficacy to treat GERD symptoms after the interim analysis.
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fexofenadine then Placebo
Arm Type
Experimental
Arm Description
Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
Arm Title
Placebo then Fexofenadine
Arm Type
Experimental
Arm Description
Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.
Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Intervention Description
Fexofenadine 180 mg in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo - Cap
Intervention Description
Placebo cap in the morning
Primary Outcome Measure Information:
Title
Mean Percent of Days With Reflux
Time Frame
2 weeks per treatment
Title
Mean Number of Reflux Episodes Per Day
Time Frame
2 weeks per treatment
Title
Mean GERD-HRQL Questionnaire Score
Description
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
Title
Mean Symptom Severity Score
Description
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
Title
Mean Rescue Medications Per Day
Description
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
Secondary Outcome Measure Information:
Title
Patient Medication Preference
Description
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)
Title
Count of Participants With Side Effects
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford Health Care
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Fexofenadine Use in Gastroesophageal Reflux Symptoms
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