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Fexofenadine Use in Gastroesophageal Reflux Disease

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ClinicalTrials.gov Identifier: NCT03425097
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Zikos, Stanford University

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Fexofenadine Drug: Placebo - Cap Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fexofenadine then Placebo
Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
Drug: Fexofenadine
Fexofenadine 180 mg in the morning
Drug: Placebo - Cap
Placebo cap in the morning
Experimental: Placebo then Fexofenadine
Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.
Drug: Fexofenadine
Fexofenadine 180 mg in the morning
Drug: Placebo - Cap
Placebo cap in the morning



Primary Outcome Measures :
  1. Mean percentage of reflux free days [ Time Frame: During the first week of treatment and separately during the second week of treatment ]
  2. Mean number of reflux episodes per day [ Time Frame: During the first week of treatment and separately during the second week of treatment ]

Secondary Outcome Measures :
  1. Mean GERD-HRQL questionnaire score [ Time Frame: During the second week of treatment ]
  2. Mean symptom severity score [ Time Frame: During the first week of treatment and separately during the second week of treatment ]
    Severity of reflux symptoms on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe)

  3. Mean percentage of days on which a rescue medication is needed [ Time Frame: During the first week of treatment and separately during the second week of 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)

  4. Patient medication preference [ Time Frame: 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.

  5. Side effects [ 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) ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425097


Contacts
Contact: George Triadafilopoulos, MD (650) 988-7530 vagt@stanford.edu
Contact: Thomas A Zikos, MD zikosta@stanford.edu

Locations
United States, California
Silicon Valley Gastroenterology 2490 Hospital Dr. Suite 211 Recruiting
Mountain View, California, United States, 94040
Contact: George Triadafilopoulos, MD    650-988-7530    vagt@stanford.edu   
Sponsors and Collaborators
Stanford University

Responsible Party: Thomas Zikos, Fellow in Gastroenterology, Stanford University
ClinicalTrials.gov Identifier: NCT03425097     History of Changes
Other Study ID Numbers: IRB-44650
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs