A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
Public ClinicalTrials.gov record NCT01926444. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01926444
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 308 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- Feb 28, 2014
- Completion
- Feb 28, 2014
- Last update posted
- May 7, 2019
2013 – 2014
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| Precision Research Institute | Chula Vista | California | 91910 | — |
| Precision Research Institute | San Diego | California | 92114 | — |
| Avail Clinical Research LLC | DeLand | Florida | 32720 | — |
| The Center for GI Disorders | Hollywood | Florida | 33021 | — |
| Mid-Atlantic Medical Research Centers | Hollywood | Maryland | 20636 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55910 | — |
| PharmaTrials | Hillsborough | New Jersey | 08844 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina | 29118 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01926444, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2019 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01926444 live on ClinicalTrials.gov.