{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2013"],"condition":["Analgesia","Visceral Pain","Pain","Colorectal cancer","Colonic Diseases","Cancer"],"disease":["Visceral Pain","Analgesia","Pain","Colorectal Cancer","Colonic Diseases","Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2150376"],"location":["Canada","United States"],"study_start_month":["7"],"keyword":["Prevention","Hydrogen sulfide","Peripheral","Kappa","CRC screening","Colonoscopy","Pain management","Colonic","Trimebutine","Oral","Opioid agonist","Sedation-free"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy","description":"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).","dates":{"creation":"2013-07-15"},"accession":"2150376","cross_references":{"ClinicalTrials___gov":["NCT01926444"]}}