Baclofen for adults with GERD symptoms not helped by PPIs.
Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms
PHASE2; PHASE3 · Dhaka Medical College · NCT07063576
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dhaka Medical College (other) |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT07063576 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
Why it matters
Potential benefit: If effective, baclofen could reduce reflux symptoms and improve daily comfort for PPI non-responders.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Dhaka
- Dhaka Medical College — Dhaka, Bangladesh (RECRUITING)
Study contacts
- Study coordinator: Adnan Imtiaj Rahul, MBBS
- Email: adnanimtiaj@gmail.com
- Phone: +8801311286376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GERD - PPI Non-responders, baclofen, GERD symptoms