Botulinum Toxin Injection in Hypercontractile Esophagus

NCT01955174 ↗

Phase 2 Completed 24 enrolled Hospices Civils de Lyon

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2013-08
Primary completion: 2017-05
Completion: 2018-02

Outcome

Missed primary endpoint

paper The improvement of symptoms at 3 months was significant compared to baseline, but similar in the active treatment and sham procedure arms. PMID 30974039 ↗

paper Botulinum toxin injection is not superior to a sham procedure to improve symptoms related to hypercontractile esophageal disorders PMID 30974039 ↗

Publications

Results Mion F, Marjoux S, Subtil F, Pioche M, Rivory J, Roman S, Zerbib F. Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double-blind randomized sham-controlled study. Neurogastroenterol Motil. 2019 May;31(5):e13587. doi: 10.1111/nmo.13587. Epub 2019 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin	Protein / enzyme biologic	100 iu	Other