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

NCT07063576 | Recruiting Phase 2 DMC

• 1 other identifier: IRB-DMC/2025/70
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD - PPI Non-responders

Keywords

baclofen; GERD symptoms

Outcome Measures

Primary Outcomes (1)

• Improvement of GERD symptoms

  The improvement of GERD symptoms will be assessed by GERD Q questionnaire.

  At baseline before randomization and at week 4

Secondary Outcomes (4)

• Effect of baclofen along with conventional treatment

  At week 4

• Effect of placebo along with conventional treatment

  At 4 week

• Comparison of effects of baclofen and placebo along with conventional treatment

  At week 4

• Adverse events

  Through the completion of study approximately one year

Study Arms (2)

Baclofen

ACTIVE COMPARATOR

Tablet baclofen 10mg three times will be given along with conventional treatment

Drug: Baclofen 10mg

Placebo

PLACEBO COMPARATOR

Tablet placebo three times daily along with conventional treatment

Drug: Placebo

Interventions

Baclofen 10mg DRUG

Tablet baclofen 10mg three times daily along with conventional treatment

Baclofen

Placebo DRUG

Tablet placebo three times daily along with conventional treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Adnan Imtiaj Rahul: lead

Study Sites (1)

Dhaka Medical College

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Interventions

Baclofen

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Adnan Imtiaj Rahul, MBBS

CONTACT

+8801311286376; adnanimtiaj@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

BA (1)