Recruiting

Baclofen Impact on Gastroesophageal Reflux Disease Symptoms Management

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Study Aim

This study is evaluating how well baclofen treats symptoms of Gastroesophageal Reflux Disease (GERD) in adults, phase 2 treatment trial.

What is being tested

Baclofen 10mg

+ Placebo

Drug
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorAdnan Imtiaj Rahul
Study ContactAdnan Imtiaj Rahul, MBBS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring how adding the drug baclofen to the usual treatment might help people with symptoms of Gastroesophageal Reflux Disease (GERD). GERD is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing discomfort and other symptoms. The study is important because it seeks to determine whether baclofen can provide additional relief from these symptoms and improve the quality of life for those affected. It also aims to ensure that using baclofen is safe by keeping track of any side effects experienced by participants. Participants in the study will either receive baclofen or a placebo, in addition to their regular treatment, for a period of four weeks. They will take 10 milligrams of baclofen or the placebo three times a day. At the end of the study period, participants will visit the hospital for an assessment. Their GERD symptoms will be evaluated using a specific questionnaire both at the start and after four weeks to see if there is any improvement. Additionally, any side effects reported by participants will be recorded to assess the safety of baclofen.

Official TitleEffect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms
NCT07063576
Principal SponsorAdnan Imtiaj Rahul
Study ContactAdnan Imtiaj Rahul, MBBS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Age 18 and above

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

11 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
Tablet placebo three times daily along with conventional treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Dhaka Medical College

Dhaka, BangladeshOpen Dhaka Medical College in Google Maps
Recruiting
One Study Center