Ulimorelin Study of Efficacy and Safety (ULISES 008)

Phase 3 Completed 330 enrolled Tranzyme, Inc. Norgine · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection

Timeline

Start: 2011-02
Primary completion: 2012-03
Completion: 2012-03

Outcome

Missed primary endpoint

paper Although the efficacy of ulimorelin in reducing the duration of postoperative ileus was not demonstrated in these studies PMID 23739196 ↗

Publications

Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ulimorelin	Small molecule	160 ug/kg	Intravenous
Subject	Ulimorelin	Small molecule	480 ug/kg	Intravenous