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

Last updated: August 18, 2025
Sponsor: Adnan Imtiaj Rahul
Overall Status: Active - Recruiting

Phase

2/3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

Placebo

Baclofen 10mg

Clinical Study ID

NCT07063576
IRB-DMC/2025/70
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age 18 and above

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

Exclusion

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 asuncontrolled 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
August 01, 2025
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Dhaka Medical College

    Dhaka,
    Bangladesh

    Active - Recruiting

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