Baclofen for adults with GERD symptoms not helped by PPIs.
Official title: Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms
Run by Dhaka Medical College · NCT07063576 · Data updated 2026-11-12
This trial will test whether adding baclofen to usual treatment helps adults whose GERD symptoms persist despite taking PPIs.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Dhaka Medical College Academic / other |
| Locations | 1 site (Dhaka) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | August 20, 2025 |
| Trial ID | NCT07063576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with persistent heartburn and/or regurgitation despite at least 8 weeks of PPI therapy, a GERD-Q score ≥8, and no alarming features or contraindications are ideal candidates.
✕Probably not a fit
Patients with alarming symptoms, other esophageal disease, peptic ulcers, significant comorbidities affecting motility, renal impairment, pregnancy or lactation, or those taking drugs that interact with baclofen are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with persistent GERD symptoms despite at least 8 weeks of PPI therapy will receive either baclofen 10 mg or a matching placebo three times daily alongside their conventional treatment for four weeks. Symptoms are measured with the validated GERD-Q questionnaire at baseline and after four weeks, and patient-reported adverse events are recorded. The study compares symptom change and reports of side effects between the baclofen and placebo groups. Patients with alarming features, other esophageal disease, significant motility-impacting illnesses, renal impairment, pregnancy/lactation, or interacting medications are excluded.
Why it matters
Potential benefit: If effective, baclofen could reduce reflux symptoms and improve daily comfort for PPI non-responders.
How similar studies have gone: Earlier clinical work shows baclofen can reduce reflux episodes and help some patients with PPI-resistant GERD, but tolerability and mixed results have limited broad adoption.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and above * Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks Exclusion Criteria: * GERD symptoms with any alarming features (dysphagia, weight loss, bleeding, vomiting, and/or anemia) * 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
Where it's running
-
Dhaka Medical College
Dhaka, Bangladesh Recruiting
Study contacts
- Study coordinator: Adnan Imtiaj Rahul, MBBS
- Email: adnanimtiaj@gmail.com
- Phone: +8801311286376
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.