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NCT01285570 · ClinicalTrials.gov registry record · Phase 3

Ulimorelin Study of Efficacy and Safety (ULISES 007)

A Phase 3 study of Gastrointestinal Dysmotility, sponsored by Tranzyme.

Completed
Registry status
Phase 3
Development phase
332
Enrollment target
20
Study locations

NCT01285570 is a Phase 3 study of Gastrointestinal Dysmotility that has completed, run by Tranzyme. The registered enrollment target is 332 participants. The trial reports 20 study locations across 13 states.

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The verdict

NCT01285570, a Phase 3 study of Gastrointestinal Dysmotility, has completed, sponsored by Tranzyme.

COMPLETED
Registry status
Phase 3
Development phase
332 participants
Enrollment target
20
Study locations

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

8 total trials

What the Registry Record Tells You About NCT01285570

The ClinicalTrials.gov registry entry for NCT01285570 describes a study currently listed as completed, categorized as Phase 3. 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 8 total studies on file at ClinicalTrials.gov.

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.

NCT01285570 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Oregon.

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.

What interventions are being tested in trial NCT01285570?

The interventions under investigation include: Ulimorelin Intravenously (IV) (DRUG), 5% dextrose in water (DRUG).

Who is sponsoring clinical trial NCT01285570?

This trial is sponsored by Tranzyme, which has 8 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.