Gastro Esophageal RefluxNCT03835442
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
A study testing Baclofen in people with Gastro Esophageal Reflux, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Reflux (acid and non-acid) mainly occurs during transient LES relaxations (TLESRs). The gamma-aminobutyric acid (GABA) receptor type B agonist baclofen was shown to inhibit TLESRs, thereby significantly decreasing acid reflux after a meal in healthy controls and in patients with GERD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 75 years old
- History of typical (heartburn/regurgitation) or atypical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks. Daily intake of PPI treatment 12 weeks prior to inclusion.
- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
Who cannot join
- Endoscopic signs of severe erosive esophagitis (≥ grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
- Systemic diseases, known to affect esophageal motility.
- Surgery in thorax or in the upper part of the abdomen.
- Treatment with baclofen prior to the start of the study.
- Regular use of medications such as: anticholinergics, tricycle antidepressants.
- Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator
Show all 10Show fewer
- Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
- Pregnancy or breast feeding.
- History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-compensated depression is allowed).
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
About this study
Reflux (acid and non-acid) mainly occurs during transient LES relaxations (TLESRs). The gamma-aminobutyric acid (GABA) receptor type B agonist baclofen was shown to inhibit TLESRs, thereby significantly decreasing acid reflux after a meal in healthy controls and in patients with GERD.
The primary objective of this study is to assess the efficacy (assessed by reflux symptom questionnaire and pH-impedance recordings) of baclofen 10mg three times daily vs. placebo in GERD patients with an incomplete response to PPI therapy.
The secondary objective is to assess the predictive value of reflux assessment (by pH-impedance recordings) on the primary outcome.
Read the detailed description
This is a randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study. Eligible subjects will be randomly assigned to receive either oral baclofen 10 mg or placebo t.i.d for a period 4 weeks. After 4 weeks all patients will be given the standard dose of baclofen 10 mg t.i.d. (open label), for another 4 weeks. The b.i.d. PPI therapy will be continued for the entire study duration.
Approximately 90 evaluable subjects with typical GERD symptoms (heartburn and/or regurgitation) will participate in this study and will be randomized on a 1:1 basis: 45 subjects each will be in the placebo and baclofen 10 mg three times daily group. Subjects will be considered to have completed the study if they complete the week 4 visit.
Medication will consist of identically-looking capsules of baclofen or placebo. Patients will take 1 capsule containing 5 mg baclofen with meals t.i.d for 7 days and then 1 capsule containing 10 mg baclofen with meals t.i.d for the remaining 21 days.
Prior to visit 1, all subjects included in the study will undergo a 24 hr pH-impedance study which was requested by the treating physician. This investigation is part of the standard clinical work up and will not be part of the study protocol.
Informed consent is to be signed and dated by the subject before any study related procedures are performed. The date of each visit to the clinic and the date and time of the last dose of test article will be recorded.
Throughout the study patients will be asked to complete daily a short questionnaire (ReQuest) for reflux symptoms.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Baclofen, Placebos
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Also called Lioresal
baclofen 10mg tid for 4 weeks
PlacebosOther
placebo tid for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| baclofen arm | Active comparator | baclofen 10mg tid for 4 weeks Receives: Drug: Baclofen |
| placebos arm | Placebo comparator | placebo tid for 4 weeks Receives: Other: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of baclofen on reflux symptom questionnaire
To assess the effect of baclofen on reflux symptom questionnaire by ReQuest
Measured: Change from baseline in ReQuest scores at 4 weeks
efficacy of baclofen on pH-impedance recordings
To assess of baclofen on 24 hour pH-impedance recordings
Measured: Change from baseline in reflux parameters (total number of reflux episodes) on 24h pH-impedance monitoring at 4 weeks
Secondary outcomes (1)
Predictive value of the reflux monitoring
To assess the predictive value of the 24 hour pH-impedance monitoring (symptom association probability = SAP) on the primary outcome
Measured: Is SAP at baseline predictor of response at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study startJan 2010
- Primary completionDec 2016
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jan Tack, PhD, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835442
- Sponsor's protocol ID
- S51996
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
- ClinicalTrials.gov ID
- NCT03835442
- Acronym / sponsor ID
- S51996
- Conditions
- Gastro Esophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 8 Feb 2019 (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.
Reflux (acid and non-acid) mainly occurs during transient LES relaxations (TLESRs). The gamma-aminobutyric acid (GABA) receptor type B agonist baclofen was shown to inhibit TLESRs, thereby significantly decreasing acid reflux after a meal in healthy controls and in patients with GERD.
The primary objective of this study is to assess the efficacy (assessed by reflux symptom questionnaire and pH-impedance recordings) of baclofen 10mg three times daily vs. placebo in GERD patients with an incomplete response to PPI therapy.
The secondary objective is to assess the predictive value of reflux assessment (by pH-impedance recordings) on the primary outcome.
Detailed description
This is a randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study. Eligible subjects will be randomly assigned to receive either oral baclofen 10 mg or placebo t.i.d for a period 4 weeks. After 4 weeks all patients will be given the standard dose of baclofen 10 mg t.i.d. (open label), for another 4 weeks. The b.i.d. PPI therapy will be continued for the entire study duration.
Approximately 90 evaluable subjects with typical GERD symptoms (heartburn and/or regurgitation) will participate in this study and will be randomized on a 1:1 basis: 45 subjects each will be in the placebo and baclofen 10 mg three times daily group. Subjects will be considered to have completed the study if they complete the week 4 visit.
Medication will consist of identically-looking capsules of baclofen or placebo. Patients will take 1 capsule containing 5 mg baclofen with meals t.i.d for 7 days and then 1 capsule containing 10 mg baclofen with meals t.i.d for the remaining 21 days.
Prior to visit 1, all subjects included in the study will undergo a 24 hr pH-impedance study which was requested by the treating physician. This investigation is part of the standard clinical work up and will not be part of the study protocol.
Informed consent is to be signed and dated by the subject before any study related procedures are performed. The date of each visit to the clinic and the date and time of the last dose of test article will be recorded.
Throughout the study patients will be asked to complete daily a short questionnaire (ReQuest) for reflux symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, parallel, double-blind, placebo-controlled, out-patient, single-center study
| Arm | Type | Receives |
|---|---|---|
| baclofen arm | Active comparator | Drug: Baclofenbaclofen 10mg tid for 4 weeks |
| placebos arm | Placebo comparator | Other: Placebosplacebo tid for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 75 years old
- History of typical (heartburn/regurgitation) or atypical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks. Daily intake of PPI treatment 12 weeks prior to inclusion.
- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
Key exclusion criteria (10 listed)
- Endoscopic signs of severe erosive esophagitis (≥ grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
- Systemic diseases, known to affect esophageal motility.
- Surgery in thorax or in the upper part of the abdomen.
- Treatment with baclofen prior to the start of the study.
- Regular use of medications such as: anticholinergics, tricycle antidepressants.
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 |
|---|---|---|
| BaclofenAlso: Lioresalbaclofen 10mg tid for 4 weeks | Drug | baclofen arm |
| Placebosplacebo tid for 4 weeks | Other | placebos arm |
Primary outcome
efficacy of baclofen on reflux symptom questionnaire
Time frame: Change from baseline in ReQuest scores at 4 weeks
To assess the effect of baclofen on reflux symptom questionnaire by ReQuest
efficacy of baclofen on pH-impedance recordings
Time frame: Change from baseline in reflux parameters (total number of reflux episodes) on 24h pH-impedance monitoring at 4 weeks
To assess of baclofen on 24 hour pH-impedance recordings
1 secondary outcome
Predictive value of the reflux monitoring
Time frame: Is SAP at baseline predictor of response at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jan Tack, PhD, MD principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Baclofen in people with Gastro Esophageal Reflux, run by Universitaire Ziekenhuizen KU Leuven.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of baclofen on reflux symptom questionnaire (time frame: Change from baseline in ReQuest scores at 4 weeks). The study lists 2 primary outcomes in all. 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 8 Feb 2019.