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Ulimorelin Study of Efficacy and Safety (ULISES 008)

NCT01296620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2012-07-26

No results posted yet for this 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

Conditions

  • Gastrointestinal Dysmotility

Interventions

DRUG

Ulimorelin Intravenously (IV)

160 µg/kg daily (QD)

DRUG

Ulimorelin Invtravenously (IV)

480 µg/kg daily (QD)

DRUG

5% dextrose in water

Placebo

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • Tranzyme, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • Bulgaria
  • Czechia
  • France
  • Lithuania
  • Romania

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296620 on ClinicalTrials.gov