NCT07063576 Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms
| NCT ID | NCT07063576 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Adnan Imtiaj Rahul |
| Condition | GERD - PPI Non-responders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-08-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to assess the effect of using baclofen along with conventional treatment in improving GERD symptoms. It will also assess the safety of drug baclofen by recording the patient reported adverse events. The main questions it aims to answer are : 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07063576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying GERD - PPI Non-responders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07063576 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07063576 currently recruiting?
Yes, NCT07063576 is actively recruiting participants. Contact the research team at adnanimtiaj@gmail.com for enrollment information.
Where is the NCT07063576 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT07063576 clinical trial?
NCT07063576 is sponsored by Adnan Imtiaj Rahul. The trial plans to enroll 60 participants.