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NCT03113396
Baclofen for Rumination
Phase 4 trial testing Baclofen in Rumination in 20 participants. Completed in 31 December 2016.
31 December 2016
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 February 2012 |
| Primary completion | 31 December 2016 |
| Estimated completion | 31 December 2016 |
Drugs / interventions tested
- Baclofen (BACLOFEN) — full drug profile →
- Placebo oral capsule
Conditions studied
- Rumination — all drugs for Rumination →
- Supra-gastric Belching — all drugs for Supra-gastric Belching →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
Adults 18 to 75, any sex, with Rumination or Supra-gastric Belching. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010-2025): 15 Years of Progress (or Lack Thereof).
Hirsch D, Reed J, Naqvi A, Ngor A, et al · · 2026 · PMID 41313392 · DOI 10.1007/s40263-025-01248-7
Verify or expand the search:
- PubMed search for NCT03113396
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Baclofen
Trials testing the same drug.
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- NCT05975684 — Baclofen for Children With Rumination Syndrome · Phase 3 · completed
- NCT05418049 — Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge · Phase 2 · active not recruiting
- NCT05161351 — Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. · Phase 4 · completed
Other recruiting trials for Rumination
Currently open trials in the same condition.
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Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03113396 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 13 April 2017
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