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COMPLETED Phase 2

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

NCT01926444 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 308 participants
Start Date 2013-07
Est. Completion 2014-03
Phase Phase 2

Sponsor

gicare Pharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01926444

The ClinicalTrials.gov registry entry for NCT01926444 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is gicare Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01926444 reports 15 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01926444?

The interventions under investigation include: GIC-1001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01926444?

This trial is sponsored by gicare Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial