Tranzyme Pharma (Research Triangle Park), began the initiation of a Phase IIb clinical trial of its investigational drug, TZP-101, for the management of post-operative ileus (POI).
TZP-101 is a potent ghrelin agonist that Tranzyme is developing as a first-in-class prokinetic agent for the treatment of POI and severe gastroparesis.
The POI Phase IIb trial, now underway in the USA, Romania and Lithuania, is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to assess the efficacy and safety of TZP-101 when administered as a 30 minute i.v. infusion to subjects undergoing major open abdominal surgery.
The study has an adaptive randomization design, and could potentially enroll up to 250 patients. The primary objective of this study is to assess the impact of TZP-101 on postoperative time to recovery of gastrointestinal (GI) function as defined by the time to first bowel movement. In addition to efficacy monitoring, routine clinical, laboratory and ECG monitoring will be performed to evaluate patient safety.
Read the complete news release.
