GERD - PPI Non-respondersPhase 2/3NCT07063576
Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms
A Phase 2/3 study testing Baclofen 10mg in people with GERD - PPI Non-responders, run by Adnan Imtiaj Rahul at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD - PPI Non-responders
- What is being tested?
- Baclofen 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Aug 2025to Jul 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Baclofen as an Add on Therapy 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.
Read more
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
- Being tested
- Baclofen 10mg, Placebo
- Keywords
- baclofen, GERD symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen 10mgDrug
Tablet baclofen 10mg three times daily along with conventional treatment
PlaceboDrug
Tablet placebo three times daily along with conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Active comparator | Tablet baclofen 10mg three times will be given along with conventional treatment Receives: Drug: Baclofen 10mg |
| Placebo | Placebo comparator | Tablet placebo three times daily along with conventional treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of GERD symptoms
The improvement of GERD symptoms will be assessed by GERD Q questionnaire.
Measured: At baseline before randomization and at week 4
Secondary outcomes (4)
Effect of baclofen along with conventional treatment
Effect of baclofen along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
Measured: At week 4
Effect of placebo along with conventional treatment
Effect of placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
Measured: At 4 week
Comparison of effects of baclofen and placebo along with conventional treatment
Comparison of effects of baclofen and placebo along with conventional treatment including PPI on GERD symptoms will be assessed by GERD Q questionnaire
Measured: At week 4
Adverse events
Patients reported adverse events will be documented
Measured: Through the completion of study approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Aug 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD - PPI Non-respondersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adnan Imtiaj Rahul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adnan Imtiaj Rahul, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063576
- Sponsor's protocol ID
- IRB-DMC/2025/70
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms
- ClinicalTrials.gov ID
- NCT07063576
- Acronym / sponsor ID
- IRB-DMC/2025/70
- Conditions
- GERD - PPI Non-responders
- Keywords
- baclofen, GERD symptoms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Adnan Imtiaj RahulUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Active comparator | Drug: Baclofen 10mgTablet baclofen 10mg three times will be given along with conventional treatment |
| Placebo | Placebo comparator | Drug: PlaceboTablet placebo three times daily along with conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen 10mgTablet baclofen 10mg three times daily along with conventional treatment | Drug | Baclofen |
| PlaceboTablet placebo three times daily along with conventional treatment | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Effect of baclofen along with conventional treatment
Time frame: At week 4
Effect of placebo along with conventional treatment
Time frame: At 4 week
Comparison of effects of baclofen and placebo along with conventional treatment
Time frame: At week 4
Adverse events
Time frame: Through the completion of study approximately one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baclofen 10mg in people with GERD - PPI Non-responders, run by Adnan Imtiaj Rahul at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adnan Imtiaj Rahul, MBBS (+8801311286376, adnanimtiaj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of GERD symptoms (time frame: At baseline before randomization and at week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.