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Completed

NCT Number: NCT01296620

Ulimorelin Study of Efficacy and Safety (ULISES 008)

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

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Key information

Conditions

Gastrointestinal Dysmotility

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMHAT Emergency Medicine, Sifua, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulimorelin Intravenously (IV)

Drug

160 µg/kg daily (QD)

Ulimorelin Invtravenously (IV)

Drug

480 µg/kg daily (QD)

5% dextrose in water

Drug

Placebo

Primary outcomes

  1. Recovery of GI Function

    Time frame: up to 7 days of dosing or until hospital discharge

Secondary outcomes

  1. Ancillary GI Functions

    Time frame: up to 7 days of dosing or hospital discharge

Sponsors and collaborators

Lead sponsor

Tranzyme, Inc.

Industry

Collaborators

  • Norgine

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2011
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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