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The study was terminated due to insufficient evidence for Fexofenadine efficacy to treat GERD symptoms after the interim analysis.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexofenadine then Placebo | Experimental | Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo. |
|
| Placebo then Fexofenadine | Experimental | Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine | Drug | Fexofenadine 180 mg in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Count of Participants With Side Effects |
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Inclusion Criteria:
Exclusion Criteria (selected)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Redwood City | California | 94063 | United States |
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Participants entered a 7 day run in period prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (2 Weeks) |
| |||||||||||||
| Washout Period (1 Week) |
| |||||||||||||
| Second Treatment Period (2 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age data are available for only 6 participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent of Days With Reflux | Participants with available data are included in the analysis. | Posted | Mean | 95% Confidence Interval | percentage of days | 2 weeks per treatment |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fexofenadine | Fexofenadine (180 mg) for 2 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nosebleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
This study was underpowered as it did not meet its planned sample size of 40 participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas A Zikos, MD | Stanford University | (408) 426-5599 | zikosta@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Nov 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C093230 | fexofenadine |
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| Placebo - Cap | Drug | Placebo cap in the morning |
|
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) |
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| NOT COMPLETED |
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Sex data are available for only 9 participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data are available for only 9 participants | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Mean Number of Reflux Episodes Per Day | Participants with available data are included in the analysis | Posted | Mean | 95% Confidence Interval | episodes | 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. | Participants with available data are included in the analysis | Posted | Mean | 95% Confidence Interval | score on a scale | 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) | Participants with available data are included in the analysis | Posted | Mean | 95% Confidence Interval | score on a scale | 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) | Participants with available data are included in the analysis | Posted | Mean | 95% Confidence Interval | medications | 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. | Data were not collected for this outcome measure | Posted | 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. | Participants with available data are included in the analysis. | Posted | Count of Participants | Participants | Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks) |
|
|
|
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Placebo | Fexofenadine placebo for 2 weeks | 0 | 11 | 0 | 11 | 0 | 11 |
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| D004066 | Digestive System Diseases |