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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03425097

Enrollment

Registered

2018-02-07

Start date

2018-02-07

Completion date

2019-01-08

Last updated

2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

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.

Interventions

DRUGFexofenadine

Fexofenadine 180 mg in the morning

DRUGPlacebo - Cap

Placebo cap in the morning

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Number of Reflux Episodes Per Day	2 weeks per treatment	—
Mean Symptom Severity Score	2 weeks per treatment	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	2 weeks per 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)
Mean Percent of Days With Reflux	2 weeks per treatment	—
Mean GERD-HRQL Questionnaire Score	2 weeks per treatment	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.

Secondary

Measure	Time frame	Description
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)	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.
Patient Medication Preference	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.

Countries

United States

Participant flow

Pre-assignment details

Participants entered a 7 day run in period prior to randomization.

Participants by arm

Arm	Count
All Participants Patients in this group will get 2 weeks of fexofenadine (180 mg) or matching placebo, then 1 week of nothing, then 2 weeks of the opposite treatment.	11
Total	11

Baseline characteristics

Characteristic	All Participants
Age, Customized 40-49 years	1 Participants
Age, Customized 50-59 years	1 Participants
Age, Customized 60-69 years	2 Participants
Age, Customized 70-79 years	1 Participants
Age, Customized 80-89 years	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Region of Enrollment United States	11 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 11
other Total, other adverse events	1 / 11	0 / 11
serious Total, serious adverse events	0 / 11	0 / 11

Outcome results

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.