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

Phase 2

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: AGN 203818; Drug: placebo

• Registration Number: NCT00441766
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-27
• Study First Submitted QC: 2007-02-27
• Study Start: 2007-03
• Study First Posted: 2007-03-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2011-12
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2011-12-16
• Last Update Submitted: 2011-12-16
• Results First Posted: 2012-01-20
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 213

Inclusion Criteria

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

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Exclusion Criteria

• Any other uncontrolled disease
• Pregnant or nursing females

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN 203818 3 mg	AGN 203818	Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks
AGN 203818 20 mg	AGN 203818	Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
AGN 203818 60 mg	AGN 203818	Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
Placebo	placebo	Part A: Placebo capsule every 12 hours for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Highest-Average-Pain Score at Week 4	Baseline, Week 4	Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4	Week 4	Percentage of patients who rated their condition as improved on the SGIC at week 4. The SGIC score was assessed using a 7-point scale (score of 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). Patients self-evaluated their overall change in symptoms (relief from symptoms of abdominal discomfort, pain, and altered bowel habits). An "improved" condition was defined as a score of 1, 2, or 3.
Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4	Week 4	Percentage of patients who experienced AR-IBS at week 4. The AR-IBS is a self-evaluation by the patient of their perception of adequate relief of IBS pain over the last 7 days following treatment as compared to IBS pain before receiving treatment. Patients respond with either a "Yes" or "No", where "Yes" indicated adequate relief of pain and "No" indicated no relief from pain.
Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)	Baseline, Week 4	Change from baseline in the frequency of bowel movements per day using the BSS. The BSS categorizes stool based on the patient's description of its consistency. Patients are classified into 3 IBS subtypes according to their predominant stool patterns (C=constipation; D=diarrhea; M=mixed). A positive change from baseline in the IBS-C indicates improvement and a negative change from baseline in the IBS-D and IBS-M indicates improvement.