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NCT01926444 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
A Phase 2 study of Cancer and Pain, sponsored by gicare Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 308
- Enrollment target
- 15
- Study locations
NCT01926444: Completed Phase 2 study of Cancer and Pain, sponsored by gicare Pharma.
NCT01926444 is a Phase 2 study of Cancer and Pain that has completed, run by gicare Pharma. The registered enrollment target is 308 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (91% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01926444, a Phase 2 study of Cancer and Pain, has completed, sponsored by gicare Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 308 participants
- Enrollment target
- 15
- Study locations
Study 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).
Primary Outcome
The Primary Outcomes Measure was the pain VAS 100-mm AUC (0mm = no pain; 100mm = worst pain), constructed from serial pain VAS measurements performed during colonoscopy. At least 8 pain VAS measurements were made, and the length of the colonoscope inserted (or removed on the way out) was recorded at every measurement. The X-axis of the VAS versus anatomical locations was defined accordingly: each VAS value corresponded to a relative length of inserted colonoscope (d/2Lc) of the X axis, where d w
Conditions Studied
Interventions
- DRUG GIC-1001
Study Locations (15)
California
- Anaheim Clinical Trials - Anaheim
- Precision Research Institute - Chula Vista
- Precision Research Institute - San Diego
Florida
- Avail Clinical Research LLC - DeLand
- The Center for GI Disorders - Hollywood
Quebec
- Clinique 1037 - Montreal
- Spécialistes MD Specialists - Montreal
Arizona
- Mayo Clinic - Scottsdale
Maryland
- Mid-Atlantic Medical Research Centers - Hollywood
Minnesota
- Mayo Clinic Rochester - Rochester
New Jersey
- PharmaTrials - Hillsborough
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01926444 record still lists
NCT01926444 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which GIC-1001 is the first listed.
NCT01926444 lists 15 locations in 11 states (California, Florida, Quebec).
Frequently Asked Questions
What is clinical trial NCT01926444 about?
NCT01926444 is a clinical study titled "A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy". 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 24...
What is the current status of trial NCT01926444?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2013-07. Estimated completion is 2014-03.
What conditions does trial NCT01926444 study?
This clinical trial studies the following conditions: Cancer, Pain, Colonic Diseases.
What interventions are being tested in trial NCT01926444?
The interventions under investigation include: GIC-1001 (DRUG).
Who is sponsoring clinical trial NCT01926444?
This trial is sponsored by gicare Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01926444 being conducted?
This trial has 15 study locations across Arizona, California, Florida, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01926444's enrollment target sits among peer trials
308 177th of 615 higher than 439 of 615 other Cancer trials
participants (enrollment target), bucketed by value
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