Gastroesophageal RefluxPhase 2NCT03425097
Fexofenadine Use in Gastroesophageal Reflux Symptoms
A Phase 2 study testing Fexofenadine in people with Gastroesophageal Reflux, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Fexofenadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 8 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Esophageal stricture
- Primary esophageal motility disorder
- Systemic sclerosis
- Active inflammatory bowel disease
- Zollinger-Ellison syndrome
- Active gastric or duodenal ulcer
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care
Redwood City, California, 94063
About this study
Official title: A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Fexofenadine, Placebo - Cap
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexofenadineDrug
Fexofenadine 180 mg in the morning
Placebo - CapDrug
Placebo cap in the morning
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine then Placebo | Experimental | Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo. Receives: Drug: Fexofenadine; Drug: Placebo - Cap |
| Placebo then Fexofenadine | Experimental | Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine. Receives: Drug: Fexofenadine; Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent of Days With Reflux
Measured: 2 weeks per treatment
Mean Number of Reflux Episodes Per Day
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 2 weeks per treatment
Secondary outcomes (2)
Patient Medication Preference
Patients will be asked which medication they think better helps treat their reflux symptoms, placebo or Fexofenadine.
Measured: Will be assessed at the end of the trial (total trial time is 6 weeks)
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.
Measured: Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start7 Feb 2018
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Why it stopped: The study was terminated due to insufficient evidence for Fexofenadine efficacy to treat GERD symptoms after the interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Zikos, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425097
- Sponsor's protocol ID
- IRB-44650
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2018
- Last updated
- 17 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms
- ClinicalTrials.gov ID
- NCT03425097
- Acronym / sponsor ID
- IRB-44650
- Conditions
- Gastroesophageal Reflux
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to insufficient evidence for Fexofenadine efficacy to treat GERD symptoms after the interim analysis.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 17 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine then Placebo | Experimental | Drug: Fexofenadine, Drug: Placebo - CapPatients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo. |
| Placebo then Fexofenadine | Experimental | Drug: Fexofenadine, Drug: Placebo - CapPatients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- Esophageal stricture
- Primary esophageal motility disorder
- Systemic sclerosis
- Active inflammatory bowel disease
- Zollinger-Ellison syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FexofenadineFexofenadine 180 mg in the morning | Drug | Fexofenadine then Placebo, Placebo then Fexofenadine |
| Placebo - CapPlacebo cap in the morning | Drug | Fexofenadine then Placebo, Placebo then Fexofenadine |
Primary outcome
Mean Percent of Days With Reflux
Time frame: 2 weeks per treatment
Mean Number of Reflux Episodes Per Day
Time frame: 2 weeks per treatment
Mean GERD-HRQL Questionnaire Score
Time frame: 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.
Mean Symptom Severity Score
Time frame: 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
Time frame: 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)
2 secondary outcomes
Patient Medication Preference
Time frame: Will be assessed at the end of the trial (total trial time is 6 weeks)
Count of Participants With Side Effects
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fexofenadine in people with Gastroesophageal Reflux, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent of Days With Reflux (time frame: 2 weeks per treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.