Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms
NCT ID: NCT07063576
Last Updated: 2025-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2025-08-01
2026-07-31
Brief Summary
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Does drug baclofen along with conventional treatment has any effect on patients with GERD symptoms? What medical problems do participants have when taking drug baclofen? Researcher will compare drug baclofen along with conventional treatment to a control group taking placebo along with conventional treatment.
Participants will:
Take drug baclofen 10 milligrams or placebo three times daily along with conventional treatment for 4 weeks. They will visit the hospital after 4 weeks. Their symptoms will be assessed via validated GERD Q questionnaire at baseline and after 4 weeks. Additionally, patient reported adverse events will be documented.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Baclofen
Tablet baclofen 10mg three times will be given along with conventional treatment
Baclofen 10mg
Tablet baclofen 10mg three times daily along with conventional treatment
Placebo
Tablet placebo three times daily along with conventional treatment
Placebo
Tablet placebo three times daily along with conventional treatment
Interventions
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Baclofen 10mg
Tablet baclofen 10mg three times daily along with conventional treatment
Placebo
Tablet placebo three times daily along with conventional treatment
Eligibility Criteria
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Inclusion Criteria
* Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
Exclusion Criteria
* Baseline GERD Q score less than 8
* Peptic gastric or duodenal ulcer on endoscopy
* Other esophageal disease like achalasia, carcinoma, corrosive stricture
* Gastrointestinal malignancy
* History of major gastrointestinal surgery
* Medical disease that affects the esophageal or gastric motility, such as uncontrolled diabetes, hyperthyroidism, hypothyroidism
* Patient with renal impairment
* Pregnant and lactating women
* Use of drugs affecting on LES
* Regular use of drug that may interact with Baclofen
18 Years
ALL
No
Sponsors
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Adnan Imtiaj Rahul
OTHER
Responsible Party
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Adnan Imtiaj Rahul
Principal investigator
Locations
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Dhaka Medical College
Dhaka, , Bangladesh
Countries
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Central Contacts
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Other Identifiers
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IRB-DMC/2025/70
Identifier Type: -
Identifier Source: org_study_id
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