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NCT01955174: TIBOH
Endoscopic Injection of Botulinum Toxin in Patients With Hypercontractile Esophageal Motility Disorders: a Prospective, Randomized, Double-blind, Controlled Study
Phase 2 trial testing Esophageal endoscopic injection of botulinum toxin in Nutcracker Oesophagus in 24 participants. Completed in 1 February 2018.
1 May 2017
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 August 2013 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 February 2018 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Esophageal endoscopic injection of botulinum toxin — full drug profile →
- No injection of botulinum toxin
Conditions studied
- Nutcracker Oesophagus — all drugs for Nutcracker Oesophagus →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Nutcracker Oesophagus. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Clinical response
Time frame: 3 months after Botulinum toxin injection or sham procedure
Determination of the percentage of patients with clinical response defined by a global Eckardt score \<3 and individual subscores \<2
Sponsor's own description
This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to hypercontractile esophageal motility disorders.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double-blind randomized sham-controlled study.
Mion F, Marjoux S, Subtil F, Pioche M, et al · · 2019 · cited 20× · PMID 30974039 · DOI 10.1111/nmo.13587
Verify or expand the search:
- PubMed search for NCT01955174
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01955174 (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 Hospices Civils de Lyon
- Last refreshed: 13 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01955174.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing