Fexofenadine Use in Gastroesophageal Reflux Symptoms

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03425097
• Other study ID #: IRB-44650
• Status: Terminated
• Phase: Phase 2
• Start date: February 7, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

Drug:
• Fexofenadine
Fexofenadine 180 mg in the morning
• Placebo - Cap
Placebo cap in the morning

Locations

Country	Name	City	State
United States	Stanford Health Care	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent of Days With Reflux		2 weeks per treatment
Primary	Mean Number of Reflux Episodes Per Day		2 weeks per treatment
Primary	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
Primary	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
Primary	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	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)
Secondary	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)