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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: placebo; Drug: AGN 203818

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441766

203818-008

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Any other uncontrolled disease
• Pregnant or nursing females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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213 participants in 4 patient groups, including a placebo group

AGN 203818 3 mg

Experimental group

Description:

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

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

AGN 203818 20 mg

Experimental group

Description:

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

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

AGN 203818 60 mg

Experimental group

Description:

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

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

Placebo

Placebo Comparator group

Description:

Part A: Placebo capsule every 12 hours for 4 weeks

Treatment:

Drug: placebo