Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07063576

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

Led by Adnan Imtiaj Rahul · Updated on 2025-08-20

60

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 and above
  • Patients with persistent GERD symptoms (heartburn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
Not Eligible

You will not qualify if you...

  • GERD symptoms with any alarming features such as dysphagia, weight loss, bleeding, vomiting, or anemia
  • Baseline GERD Q score less than 8
  • Peptic gastric or duodenal ulcer found by endoscopy
  • Other esophageal diseases like achalasia, carcinoma, or corrosive stricture
  • Gastrointestinal malignancy
  • History of major gastrointestinal surgery
  • Medical diseases affecting esophageal or gastric motility such as uncontrolled diabetes, hyperthyroidism, or hypothyroidism
  • Renal impairment
  • Pregnant or lactating women
  • Use of drugs affecting the lower esophageal sphincter
  • Regular use of drugs that may interact with baclofen

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dhaka Medical College

Dhaka, Bangladesh

Actively Recruiting

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Research Team

A

Adnan Imtiaj Rahul, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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