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Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain

NCT00441766 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2012-01-20

Study results available
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Summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

AGN 203818

Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks

DRUG

AGN 203818

Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks

DRUG

AGN 203818

Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks

DRUG

placebo

Part A: placebo capsule every 12 hours for 4 weeks

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-02-29
Completion
2008-02-29

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 NCT00441766 on ClinicalTrials.gov