Ulimorelin Study of Efficacy and Safety (ULISES 007)

Phase 3

Completed

• Conditions: Gastrointestinal Dysmotility
• Interventions: Drug: Ulimorelin Intravenously (IV); Drug: 5% dextrose in water

• Registration Number: NCT01285570
• Lead Sponsor: Tranzyme, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Men or women, 18 to 80 years of age, inclusive
• Scheduled to undergo open bowel resection with colonic anastomosis.
• For women who can potentially become pregnant a pregnancy test at screening and admission must be negative.

Exclusion Criteria

• Weight more than 200kg (441 pounds)
• Pregnant or breastfeeding
• Known history of drug or alcohol abuse within the previous year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 2	Ulimorelin Intravenously (IV)	-
experimental 1	Ulimorelin Intravenously (IV)	-
Placebo	5% dextrose in water	Placebo comparator daily (QD)

Primary Outcome Measures

Name	Time	Method
Recovery of GI Function	up to 7 days of dosing or until hospital discharge

Secondary Outcome Measures

Name	Time	Method
Ancillary GI Functions	up to 7 days of dosing or hospital discharge

Trial Locations

Locations (45)

Fountain Valley Regional Hospital; 🇺🇸 Fountain Valley, California, United States

Orange Coast Memorial Med. Ctr.; 🇺🇸 Fountain Valley, California, United States

USC, Colorectal Surgery Division; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Denver VA Medical Center; 🇺🇸 Denver, Colorado, United States

Nature Coast Clinical Research; 🇺🇸 Inverness, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Pensacola Research Consultants; 🇺🇸 Pensacola, Florida, United States

Sunrise Clinical Research, Inc.; 🇺🇸 Sunrise, Florida, United States

ARS Clinical Trials; 🇺🇸 Powder Springs, Georgia, United States

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