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COMPLETED Phase 3

Ulimorelin Study of Efficacy and Safety (ULISES 007)

NCT01285570 · View on ClinicalTrials.gov ↗

Study Summary

Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.

Interventions

  • DRUG Ulimorelin Intravenously (IV)
  • DRUG 5% dextrose in water

Study Locations (20)

California

  • Fountain Valley Regional Hospital — Fountain Valley
  • Orange Coast Memorial Med. Ctr. — Fountain Valley
  • USC, Colorectal Surgery Division — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles

Florida

  • Nature Coast Clinical Research — Inverness
  • Jacksonville Center for Clinical Research — Jacksonville
  • Pensacola Research Consultants — Pensacola
  • Sunrise Clinical Research, Inc. — Sunrise

Oregon

  • Bend Memorial Clinic — Bend
  • Mt. Talbert Medical Offices — Clackamas

Colorado

  • Denver VA Medical Center — Denver

Georgia

  • ARS Clinical Trials — Powder Springs

Illinois

  • So. Illinois Univ. School of Medicine — Springfield

Kentucky

  • Univ. of Louisville, Dept. of Surgery — Louisville

Massachusetts

  • UMass Memorial Medical Center — Worcester

Trial Details

FieldValue
Enrollment Target 332 participants
Start Date 2011-01
Est. Completion 2012-01
Phase Phase 3

Sponsor

Tranzyme

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01285570

The ClinicalTrials.gov registry entry for NCT01285570 describes a study currently listed as completed. It is categorized as Phase 3, 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 332 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tranzyme, 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 1 condition, with Gastrointestinal Dysmotility appearing as the primary indexed condition, and to 2 interventions — of which Ulimorelin Intravenously (IV) 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: NCT01285570 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Oregon. 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 NCT01285570 about?

NCT01285570 is a clinical study titled "Ulimorelin Study of Efficacy and Safety (ULISES 007)". Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.

What is the current status of trial NCT01285570?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 332 participants. The study started on 2011-01. Estimated completion is 2012-01.

What conditions does trial NCT01285570 study?

This clinical trial studies the following conditions: Gastrointestinal Dysmotility. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01285570?

The interventions under investigation include: Ulimorelin Intravenously (IV) (DRUG), 5% dextrose in water (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01285570?

This trial is sponsored by Tranzyme, 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 NCT01285570 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. 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