Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms

Not Applicable

Recruiting

• Conditions: GERD - PPI Non-responders
• Interventions: Drug: Baclofen 10mg; Drug: Placebo

• Registration Number: NCT07063576
• Lead Sponsor: Adnan Imtiaj Rahul

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-03
• Study First Posted: 2025-07-14
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baclofen	Baclofen 10mg	Tablet baclofen 10mg three times will be given along with conventional treatment
Placebo	Placebo	Tablet placebo three times daily along with conventional treatment

Primary Outcome Measures

Name	Time	Method
Improvement of GERD symptoms	At baseline before randomization and at week 4	The improvement of GERD symptoms will be assessed by GERD Q questionnaire.

Secondary Outcome Measures

Name	Time	Method
Effect of baclofen along with conventional treatment	At week 4	Effect of baclofen along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
Effect of placebo along with conventional treatment	At 4 week	Effect of placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
Comparison of effects of baclofen and placebo along with conventional treatment	At week 4	Comparison of effects of baclofen and placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
Adverse events	Through the completion of study approximately one year	Patients reported adverse events will be documented

Trial Locations

Locations (2)

Dhaka Medical College; 🇧🇩 Dhaka, Bangladesh

Dhaka Medical College; 🇧🇩 Dhaka, Bangladesh