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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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).

Detailed Summary:

1. Study Objectives

   1.1 Primary objective: The primary objective of this Phase IIa study is to establish clinical Proof-of-Concept (POC) by providing clinically and statistically significant evidence that GIC-1001 is safe and effective in managing visceral pain in male and female patients who undergo sedation-free, full colonoscopy for preventive purposes.

   1.2 Secondary objectives: Secondary objectives will include the selection of the optimal dose of GIC-1001 from a safety/efficacy ratio point of view, establish a preliminary safety profile of the drug in patients, and obtain a preliminary general efficacy profile of GIC-1001 by assessing various secondary endpoints

2. Study Endpoints

   2.1 Primary endpoints:

   Visceral pain will be assessed using a 100-mm VAS, measured at various times and anatomical segments (N: 8) throughout the colon, i.e.:

   1. Prior to intra-rectal insertion of the endoscope;
   2. After insertion through the anus;
   3. After passage through the rectosigmoid segment;
   4. Immediately after passage through the splenic flexure;
   5. Immediately after passage through the hepatic flexure;
   6. Once the caecum is reached;
   7. Immediately after passage through the splenic flexure during scope withdrawal; and
   8. At the end of the procedure, once the colonoscope has been c
      Sponsor: gicare Pharma Inc.
      

      Current Primary Outcome: Measurements of visceral pain, using a 100-mm Visual Analog Scale (VAS) [ Time Frame: Assessed at different anatomical locations: (1) before colonoscopy, (2) insertion of scope in anus, (3) at rectosigmoid flexure, (4) at splenic flexure, (5) at hepatic flexure, (6) at caecum, (7) at splenic flexure on wayback, (8) after colonoscopy. ]

      The patient will mark the 100-mm VAS line at each anatomical locations. A score (mark) at zero means no pain and a score of 100 means extreme pain experienced. Each VAS score will be associated to an anatomical location, such location being converted into the distance of inserted colonoscope. All data will translate into a curve, where Y-axis is VAS values and X-axis is scope distance, then the AUC will be the overall pain experienced during the colonoscopy
      
      
      

      Original Primary Outcome: Same as current
      
      

      Current Secondary Outcome:

      • Time to Caecum [ Time Frame: Measured during colonoscopy ]
        Time to Caecum is the time taken by the physician to reach the caecum with the colonoscope, from the insertion in the anus.
      • Colonoscopy completion rate (%) [ Time Frame: Number of patients during trial with a complete colonoscopy, where the scope has reached the caecum during the colonoscopy ]
        Qualitative outcome: colonoscopy completion is defined as a procedure performed entirely, from initial anal insertion, reaching of caecum, and complete removal of the scope. Completion rate is then the number of patient (%) with a complete colonoscopy (up to the caecum) divided by the number of trial participants.
      • Safety [ Time Frame: Assessed before drug treatment, on Day 2 of the 3-day dose regimen, before and after the colonoscopy (Day4), followed by 2 safety call after 48 hours post-colonosocpy and 7 days post-colonoscopy. ]
        Physical exams, safety lab tests, EKG and adverse events reporting
      
      
      

      Original Secondary Outcome: Same as current
      
      Information By: gicare Pharma Inc.
      

      Dates:
      Date Received: August 8, 2013
      Date Started: July 2013
      Date Completion:
      Last Updated: August 8, 2016
      Last Verified: August 2016