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Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

NCT00454688 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2011-10-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Asimadoline

Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks

DRUG

Placebo

Placebo was provided in coated tablets identical in appearance to asimadoline tablets.

Sponsors & Collaborators

  • RTI Health Solutions

    collaborator OTHER

  • Tioga Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Allen Mangel, MD, PhD · Tioga Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2007-11-30
Completion
2007-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00454688 on ClinicalTrials.gov