Fexofenadine Use in Gastroesophageal Reflux Symptoms

• Sponsor: Stanford University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03425097
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 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: Feb 7, 2018
• Actual Primary Completion Date: Jan 8, 2019
• Actual Study Completion Date: Jan 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Percent of Days With Reflux [2 weeks per treatment]

2. Mean Number of Reflux Episodes Per Day [2 weeks per treatment]

3. 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.

4. 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)

5. 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)

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Health Care	Redwood City	California	United States	94063

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2018

More Information

Publications

None provided.

• Responsible Party: Thomas Zikos, Fellow in Gastroenterology, Stanford University
• ClinicalTrials.gov Identifier: NCT03425097
• Other Study ID Numbers: IRB-44650
• First Posted: Feb 7, 2018
• Last Update Posted: Feb 17, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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; Esophagitis, Peptic; Fexofenadine

Study Results

Participant Flow

Pre-assignment Detail	Participants entered a 7 day run in period prior to randomization.

Arm/Group Title	Fexofenadine Then Placebo	Placebo Then Fexofenadine
Arm/Group Description	Patients in this group will get 2 weeks of fexofenadine (180 mg), then 1 week of nothing, then 2 weeks of placebo.	Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine (180 mg)
Period Title: Treatment Period 1 (2 Weeks)
STARTED	6	5
COMPLETED	6	5
NOT COMPLETED	0	0
Period Title: Treatment Period 1 (2 Weeks)
STARTED	6	5
COMPLETED	6	5
NOT COMPLETED	0	0
Period Title: Treatment Period 1 (2 Weeks)
STARTED	6	5
COMPLETED	6	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	11
Age, Customized (Count of Participants)
40-49 years	1 9.1%
50-59 years	1 9.1%
60-69 years	2 18.2%
70-79 years	1 9.1%
80-89 years	1 9.1%
Sex: Female, Male (Count of Participants)
Female	2 18.2%
Male	7 63.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	9 81.8%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent of Days With Reflux
Time Frame	2 weeks per treatment

Outcome Measure Data

Analysis Population Description

Participants with available data are included in the analysis.

Arm/Group Title	Run-in Period	Fexofenadine	Placebo
Arm/Group Description	Participants entered a 1 week run-in period prior to randomization.	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	6	6	6
Mean (95% Confidence Interval) [percentage of days]	83.4	52.4	52.4

2. Primary Outcome

Title	Mean Number of Reflux Episodes Per Day
Time Frame	2 weeks per treatment

Outcome Measure Data

Analysis Population Description

Participants with available data are included in the analysis

Arm/Group Title	Run-in Period	Fexofenadine	Placebo
Arm/Group Description	Participants entered a 1 week run-in period prior to randomization.	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	6	6	6
Mean (95% Confidence Interval) [episodes]	1.74	0.69	0.67

3. Primary Outcome

Title	Mean GERD-HRQL Questionnaire Score
Description	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.
Time Frame	2 weeks per treatment

Outcome Measure Data

Analysis Population Description

Participants with available data are included in the analysis

Arm/Group Title	Run-in Period	Fexofenadine	Placebo
Arm/Group Description	Participants entered a 1 week run-in period prior to randomization.	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	6	6	6
Mean (95% Confidence Interval) [score on a scale]	16.2	9.8	12.3

4. Primary Outcome

Title	Mean Symptom Severity Score
Description	Severity of reflux symptoms on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe)
Time Frame	2 weeks per treatment

Outcome Measure Data

Analysis Population Description

Participants with available data are included in the analysis

Arm/Group Title	Run-in Period	Fexofenadine	Placebo
Arm/Group Description	Participants entered a 1 week run-in period prior to randomization.	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	6	6	6
Mean (95% Confidence Interval) [score on a scale]	1.2	0.8	0.7

5. Primary Outcome

Title	Mean Rescue Medications Per Day
Description	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)
Time Frame	2 weeks per treatment

Outcome Measure Data

Analysis Population Description

Participants with available data are included in the analysis

Arm/Group Title	Run-in Period	Fexofenadine	Placebo
Arm/Group Description	Participants entered a 1 week run-in period prior to randomization.	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	6	6	6
Mean (95% Confidence Interval) [medications]	0.29	0.52	0.17

6. Secondary Outcome

Title	Patient Medication Preference
Description	Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine.
Time Frame	Will be assessed at the end of the trial (total trial time is 6 weeks)

Outcome Measure Data

Analysis Population Description

Data were not collected for this outcome measure

Arm/Group Title	Run-in Period	Fexofenadine	Placebo
Arm/Group Description	Participants entered a 1 week run-in period prior to randomization.	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	0	0	0

7. Secondary Outcome

Title	Count of Participants With Side Effects
Description	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.
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)

Outcome Measure Data

Analysis Population Description

Participants with available data are included in the analysis.

Arm/Group Title	Fexofenadine	Placebo
Arm/Group Description	Fexofenadine (180 mg) for 2 weeks	Fexofenadine placebo for 2 weeks
Measure Participants	6	6
Count of Participants [Participants]	1 9.1%	0 NaN

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Fexofenadine		Placebo
Arm/Group Description	Fexofenadine (180 mg) for 2 weeks		Fexofenadine placebo for 2 weeks
All Cause Mortality
	Fexofenadine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Serious Adverse Events
	Fexofenadine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Fexofenadine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Nosebleed	1/11 (9.1%)		0/11 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.