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NCT Number: NCT07063576

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

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.

Recruiting

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Key information

Conditions

GERD - PPI Non-responders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dhaka Medical College

Dhaka, Bangladesh

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen 10mg

Drug

Tablet baclofen 10mg three times daily along with conventional treatment

Placebo

Drug

Tablet placebo three times daily along with conventional treatment

Primary outcomes

  1. Improvement of GERD symptoms

    Time frame: At baseline before randomization and at week 4

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

Secondary outcomes

  1. Effect of baclofen along with conventional treatment

    Time frame: At week 4

    Effect of baclofen along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire

  2. Effect of placebo along with conventional treatment

    Time frame: At 4 week

    Effect of placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire

  3. Comparison of effects of baclofen and placebo along with conventional treatment

    Time frame: 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

  4. Adverse events

    Time frame: Through the completion of study approximately one year

    Patients reported adverse events will be documented

Study contacts

Contact information is provided by the study sponsor or research team.

Adnan Imtiaj Rahul, MBBS

CONTACT

[email protected]

+8801311286376

Sponsors and collaborators

Lead sponsor

Adnan Imtiaj Rahul

Other

Registry information

Official study title

Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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