Trial Outcomes & Findings for Fexofenadine Use in Gastroesophageal Reflux Symptoms (NCT NCT03425097)

NCT ID: NCT03425097

Last Updated: 2021-02-17

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

2 weeks per treatment

Results posted on

2021-02-17

Participant Flow

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

Participant milestones

Participant milestones
Measure	Fexofenadine Then Placebo Patients in this group will get 2 weeks of fexofenadine (180 mg), then 1 week of nothing, then 2 weeks of placebo.	Placebo Then Fexofenadine Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine (180 mg)
Treatment Period 1 (2 Weeks) STARTED	6	5
Treatment Period 1 (2 Weeks) COMPLETED	6	5
Treatment Period 1 (2 Weeks) NOT COMPLETED	0	0
Washout Period (1 Week) STARTED	6	5
Washout Period (1 Week) COMPLETED	6	5
Washout Period (1 Week) NOT COMPLETED	0	0
Second Treatment Period (2 Weeks) STARTED	6	5
Second Treatment Period (2 Weeks) COMPLETED	6	5
Second Treatment Period (2 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data are available for only 6 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=11 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.
Age, Customized 40-49 years	1 Participants n=6 Participants • Age data are available for only 6 participants
Age, Customized 50-59 years	1 Participants n=6 Participants • Age data are available for only 6 participants
Age, Customized 60-69 years	2 Participants n=6 Participants • Age data are available for only 6 participants
Age, Customized 70-79 years	1 Participants n=6 Participants • Age data are available for only 6 participants
Age, Customized 80-89 years	1 Participants n=6 Participants • Age data are available for only 6 participants
Sex: Female, Male Female	2 Participants n=9 Participants • Sex data are available for only 9 participants
Sex: Female, Male Male	7 Participants n=9 Participants • Sex data are available for only 9 participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants • Ethnicity data are available for only 9 participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=9 Participants • Ethnicity data are available for only 9 participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants • Ethnicity data are available for only 9 participants
Region of Enrollment United States	11 Participants n=11 Participants

PRIMARY outcome

Timeframe: 2 weeks per treatment

Population: Participants with available data are included in the analysis.

Outcome measures

Outcome measures
Measure	Run-in Period n=6 Participants Participants entered a 1 week run-in period prior to randomization.	Fexofenadine n=6 Participants Fexofenadine (180 mg) for 2 weeks	Placebo n=6 Participants Fexofenadine placebo for 2 weeks
Mean Percent of Days With Reflux	83.4 percentage of days Interval 59.4 to 107.4	52.4 percentage of days Interval 4.3 to 100.4	52.4 percentage of days Interval 12.5 to 92.2

PRIMARY outcome

Timeframe: 2 weeks per treatment

Population: Participants with available data are included in the analysis

Outcome measures

Outcome measures
Measure	Run-in Period n=6 Participants Participants entered a 1 week run-in period prior to randomization.	Fexofenadine n=6 Participants Fexofenadine (180 mg) for 2 weeks	Placebo n=6 Participants Fexofenadine placebo for 2 weeks
Mean Number of Reflux Episodes Per Day	1.74 episodes Interval 0.73 to 2.75	0.69 episodes Interval -0.01 to 1.4	0.67 episodes Interval -0.05 to 1.29

PRIMARY outcome

Timeframe: 2 weeks per treatment

Population: Participants with available data are included in the analysis

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.

Outcome measures

Outcome measures
Measure	Run-in Period n=6 Participants Participants entered a 1 week run-in period prior to randomization.	Fexofenadine n=6 Participants Fexofenadine (180 mg) for 2 weeks	Placebo n=6 Participants Fexofenadine placebo for 2 weeks
Mean GERD-HRQL Questionnaire Score	16.2 score on a scale Interval 2.5 to 29.8	9.8 score on a scale Interval -1.5 to 21.2	12.3 score on a scale Interval 4.0 to 20.7

PRIMARY outcome

Timeframe: 2 weeks per treatment

Population: Participants with available data are included in the analysis

Severity of reflux symptoms on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe)

Outcome measures

Outcome measures
Measure	Run-in Period n=6 Participants Participants entered a 1 week run-in period prior to randomization.	Fexofenadine n=6 Participants Fexofenadine (180 mg) for 2 weeks	Placebo n=6 Participants Fexofenadine placebo for 2 weeks
Mean Symptom Severity Score	1.2 score on a scale Interval 0.6 to 1.9	0.8 score on a scale Interval -0.03 to 1.5	0.7 score on a scale Interval -0.02 to 1.4

PRIMARY outcome

Timeframe: 2 weeks per treatment

Population: Participants with available data are included in the analysis

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)

Outcome measures

Outcome measures
Measure	Run-in Period n=6 Participants Participants entered a 1 week run-in period prior to randomization.	Fexofenadine n=6 Participants Fexofenadine (180 mg) for 2 weeks	Placebo n=6 Participants Fexofenadine placebo for 2 weeks
Mean Rescue Medications Per Day	0.29 medications Interval -0.31 to 0.89	0.52 medications Interval -0.75 to 1.8	0.17 medications Interval -0.14 to 0.47

SECONDARY outcome

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

Population: Data were not collected for this outcome measure

Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Participants with available data are included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Run-in Period n=6 Participants Participants entered a 1 week run-in period prior to randomization.	Fexofenadine n=6 Participants Fexofenadine (180 mg) for 2 weeks	Placebo Fexofenadine placebo for 2 weeks
Count of Participants With Side Effects	1 Participants	0 Participants	—

Adverse Events

Fexofenadine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fexofenadine n=11 participants at risk Fexofenadine (180 mg) for 2 weeks	Placebo n=11 participants at risk Fexofenadine placebo for 2 weeks
Respiratory, thoracic and mediastinal disorders Nosebleed	9.1% 1/11 • 6 weeks	0.00% 0/11 • 6 weeks

Additional Information

Thomas A Zikos, MD

Stanford University

Phone: (408) 426-5599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place