A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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).