CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 308 enrolled
Drug / intervention
GIC-1001drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01926444
NCT01926444Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of-Concept Study of GIC-1001 for the Management of Visceral Pain in Subjects Undergoing Sedation-Free, Full Colonoscopy

gicare Pharma Inc.·interventional·Posted Aug 21, 2013·Updated May 8, 2019

In Brief

A Phase 2 clinical trial evaluating GIC-1001 for Pain and 2 related conditions. Completed, enrolled 308 participants across 15 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Cancer, Colonic Diseases
CountriesCanada, United States
CollaboratorsJSS Medical Research Inc., Algorithme Pharma Inc

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 21, 2013
Enrollment StartJul 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.9 years ago

Interventions

GIC-1001drug

GIC-1001 oral tablet, white-coated, to be taken with water