A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation… (NCT01926444) | Clinical Trial Compass
CompletedPhase 2
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
United States308 participantsStarted 2013-07
Plain-language 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).
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion criteria
✓. Signed and dated written Informed Consent obtained.
✓. Males or females.
✓. Aged 40-75 years.
✓. Indication for full colonoscopy for colorectal cancer screening or investigation, including subjects presenting suggestive symptoms and who need a differential diagnosis.
✓. Colonoscopy naïve subjects, i.e. who never underwent colonoscopy before, will be eligible, as well as non-naïve subjects who have previously undergone unsedated colonoscopy , or who had sedated colonoscopy at least 10 years prior (i.e. ≥ 10 years) to enrolment
✓. Eligible for a procedure without sedation.
✓. Able to complete questionnaires and use a Visual Analog Scale (VAS), including sufficient English, French or Spanish speaking skills as well as adequate eyesight and hearing
✓. BMI ≥ 19, BMI ≤ 40 kg/m2.
Exclusion criteria
✕. Known allergy or intolerance to trimebutine (Modulon® or generic).
✕. Known allergy or intolerance to sulfur-containing drugs (e.g. N-acetylcysteine or captopril).
✕. Previous gastrointestinal or gynecologic surgery, e.g. ileostomy, pelvic surgery,; however, patients with an appendectomy are eligible.Patients who have had a tubal ligation at least 10 years prior (i.e. ≥ 10 years) to enrolment are also eligible.
What they're measuring
1
Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)
Timeframe: 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 way back, (8) after colonoscopy.