A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy

Summary

GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative to i.v. sedation during full colonoscopy. It will be evaluated for efficacy and safety in a multi-center, randomized, double-blind, placebo controlled, dose-ranging, proof of concept Phase 2a trial. Up to 240 patients will receive one of 3 doses of GIC-1001 or its matching placebo. A pharmacokinetic evaluation will be carried out on a subset of patients (N: 24).

Timeline

Start

2013-07

Primary completion

2014-03

Completion

2014-03

Outcome

Missed primary endpoint

registry GIC-1001 Low Dose vs GIC-1001 Mid-dose vs GIC-1001 , High Dose vs GIC-1001 Matching Placebo; p = 0.506; ANOVA NCT01926444 ↗

Drugs

Indications