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

NCT ID: NCT00441766

Last Updated: 2012-01-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AGN 203818 3 mg

Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks

Group Type EXPERIMENTAL

AGN 203818

Intervention Type DRUG

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

AGN 203818 20 mg

Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks

Group Type EXPERIMENTAL

AGN 203818

Intervention Type DRUG

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

AGN 203818 60 mg

Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks

Group Type EXPERIMENTAL

AGN 203818

Intervention Type DRUG

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

Placebo

Part A: Placebo capsule every 12 hours for 4 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Part A: placebo capsule every 12 hours for 4 weeks

Interventions

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AGN 203818

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

Intervention Type DRUG

AGN 203818

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

Intervention Type DRUG

AGN 203818

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

Intervention Type DRUG

placebo

Part A: placebo capsule every 12 hours for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Irritable Bowel Syndrome
* Moderate or severe IBS pain

Exclusion Criteria

* Any other uncontrolled disease
* Pregnant or nursing females
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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203818-008

Identifier Type: -

Identifier Source: org_study_id

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