RuminationPhase 4NCT03113396
Baclofen for Rumination
A Phase 4 study testing Baclofen in people with Rumination and Supra-gastric Belching, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rumination, Supra-gastric Belching
- What is being tested?
- Baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 31 Dec 2016
- Phase
- Phase 4
- 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
- Clinical suspicion of rumination syndrome and/or supra-gastric belching.
- 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.
- 18 to 75 years old.
- 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
- 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.
- Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
- 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-controlled depression is allowed).
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
About this study
Official title: A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. Patients are asked to fill out questionnaires during the entire study period.
- Conditions
- Rumination, Supra-gastric Belching
- Being tested
- Baclofen, Placebo oral capsule
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Also called Lioresal
baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.
Placebo oral capsuleDrug
placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| baclofen | Experimental | Patients will receive baclofen (10mg t.i.d) for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is placebo (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing. Receives: Drug: Baclofen |
| placebo | Placebo comparator | Patients will receive placebo for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is baclofen (10mg t.i.d) (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
patients fill out questionnaires concerning overall wellbeing, during the 2 weeks of treatment. Results of these questionnaires will be compared between both conditions (baclofen and placebo).
Measured: 2 weeks treatment
Secondary outcomes (1)
objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring
High Resolution impedance Manometry monitoring will be performed, with a meal. We will look at the number of times patients push an event marker, the number of time patients ruminate or have supra-gastric belching or have reflux episodes, or have transient lower esophageal sphincter relaxations, both before and after the meal. And we will compare these outcomes between placebo and baclofen.
Measured: 2 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Feb 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RuminationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113396
- Sponsor's protocol ID
- S53446
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pauwels A, Broers C, Van Houtte B, Rommel N, Vanuytsel T, Tack J. A Randomized Double-Blind, Placebo-Controlled, Cross-Over Study Using Baclofen in the Treatment of Rumination Syndrome. Am J Gastroenterol. 2018 Jan;113(1):97-104. doi: 10.1038/ajg.2017.441. Epub 2017 Dec 5.
PubMed 29206813
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
- ClinicalTrials.gov ID
- NCT03113396
- Acronym / sponsor ID
- S53446
- Conditions
- Rumination, Supra-gastric Belching
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Apr 2017 (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.
Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. Patients are asked to fill out questionnaires during the entire study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| baclofen | Experimental | Drug: BaclofenPatients will receive baclofen (10mg t.i.d) for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is placebo (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing. |
| placebo | Placebo comparator | Drug: Placebo oral capsulePatients will receive placebo for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is baclofen (10mg t.i.d) (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical suspicion of rumination syndrome and/or supra-gastric belching.
- 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.
- 18 to 75 years old.
- 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 (7 listed)
- 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.
- Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
- Pregnancy or breast feeding.
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 oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing. | Drug | baclofen |
| Placebo oral capsuleplacebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing. | Drug | placebo |
Primary outcome
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
Time frame: 2 weeks treatment
patients fill out questionnaires concerning overall wellbeing, during the 2 weeks of treatment. Results of these questionnaires will be compared between both conditions (baclofen and placebo).
1 secondary outcome
objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring
Time frame: 2 weeks treatment
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 13 Apr 2017.
- Derived from this study: PubMed 29206813Pauwels A, Broers C, Van Houtte B, Rommel N, Vanuytsel T, Tack J. A Randomized Double-Blind, Placebo-Controlled, Cross-Over Study Using Baclofen in the Treatment of Rumination Syndrome. Am J Gastroenterol. 2018 Jan;113(1):97-104. doi: 10.1038/ajg.2017.441. Epub 2017 Dec 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen in people with Rumination and Supra-gastric Belching, 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 7 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 13 Apr 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire. (time frame: 2 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113396, which also lists 1 linked publication.
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 13 Apr 2017.