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

ABSTRACT: 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).

DISEASE(S): Visceral Pain,Analgesia,Pain,Colorectal Cancer,Colonic Diseases,Cancer

PROVIDER: 2150376 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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