Fexofenadine Use in Gastroesophageal Reflux Symptoms

NCT03425097 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB-44650
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Patient Medication Preference

  Will be assessed at the end of the trial (total trial time is 6 weeks)

• Count of Participants With Side Effects

  Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks)

Study Arms (2)

Fexofenadine then Placebo

EXPERIMENTAL

Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.

Drug: Fexofenadine; Drug: Placebo - Cap

Placebo then Fexofenadine

EXPERIMENTAL

Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.

Drug: Fexofenadine; Drug: Placebo - Cap

Interventions

Fexofenadine DRUG

Fexofenadine 180 mg in the morning

Fexofenadine then Placebo; Placebo then Fexofenadine

Placebo - Cap DRUG

Placebo cap in the morning

Fexofenadine then Placebo; Placebo then Fexofenadine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

This study was underpowered as it did not meet its planned sample size of 40 participants.

Results Point of Contact

• Title: Thomas A Zikos, MD
• Organization: Stanford University

zikosta@stanford.edu

(408) 426-5599

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Gastroenterology

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 7, 2018
• Study Start: February 7, 2018
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)