Fexofenadine Use in Gastroesophageal Reflux Symptoms

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

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.

Study Overview

• Status: Terminated
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Drug: Fexofenadine; Drug: Placebo - Cap

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
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: IRB-44650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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