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

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).

Conditions

• Pain
• Cancer
• Colonic Diseases

Interventions

DRUG

GIC-1001

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

Sponsors & Collaborators

• JSS Medical Research Inc.

  collaborator INDUSTRY

• Algorithme Pharma Inc

  collaborator INDUSTRY

• gicare Pharma Inc.

  lead INDUSTRY

Principal Investigators

• Mark V Larson, MD · Mayo Clinic, Rochester, MN, USA

• Michael DeMicco, MD · Anaheim Clinical Trials, Anaheim, CA, USA

• Mark Lamet, MD · The Center of GI Disorders, Hollwood, FL, USA

• Taddese Desta, MD · Precision Research Institute, San Diego, CA, USA

• Cynthia Schaeffer, MD · Precision Research Institute, Chula Vista, CA, USA

• Vivek Gumaste, MD · Montefiore Medical Center, NY, USA

• Theadore Ptak, MD · Toronto Digestive Disease Associates, Toronto, ON, Canada

• Anand Sahai, MD · Clinique 1037, Montreal, QC, Canada

• Umedchandra Shah, MD · Mid-Atlantic Medical Research Centers, Hollyword, MD, USA

• Suryakanth R. Gurudu, MD · Mayo Clinical, Scottsdale Arizona

• Robert Enns, MD · GIRI (GI Research Institute), Vancouver, Canada

• Narayanachar S Murali, MD · Gastroenterology Associates of Orangeburg, SC, USA

• Vishal Gupta, MD · Avail Clinical Research LLC

• Albert Cohen, MD · Spécialistes MD Specialists

• Vitaly Fishbein, MD · PharmaTrials

• Dennis Riff, MD · Anaheim Clinical Trials

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States
• Canada

Study Locations