GERD - PPI Non-responders study: Baclofen
Official title Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms
ClinicalTrials.gov ID: NCT07063576
What this study is testing
What is Baclofen 10mg?
An investigational oral medication being studied for improving symptoms of GERD in patients who do not respond to proton pump inhibitors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if adding baclofen improves GERD symptoms and what side effects it may cause.
- Who it's for
- Adults who have GERD symptoms and have not improved with proton‑pump inhibitors (PPIs).
- What's involved
- Participants will take either 10 mg baclofen or a placebo three times a day, plus their usual GERD medication, for 4 weeks. They will fill out a symptom questionnaire at the start and after 4 weeks, and report any side effects.
- Time commitment
- The study lasts 4 weeks, with a single follow‑up visit at the end to review symptoms and side effects.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
You likely can't join if
- 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
See the full eligibility criteria
- Age 18 and above
- Patients with persistent GERD symptoms (Heart burn and/or regurgitation) despite taking conventional treatment including PPI for 8 weeks
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dhaka, Bangladesh. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.