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