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Asimadoline for the Treatment of Post-Operative Ileus

NCT00443040 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-01-06

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

Conditions

  • Post-Operative Ileus

Interventions

DRUG

Asimadoline

Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.

DRUG

Placebo

Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.

Sponsors & Collaborators

  • RTI Health Solutions

    collaborator OTHER

  • Tioga Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Allen Mangel, MD, PhD · CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00443040 on ClinicalTrials.gov