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

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.

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: AGN 203818; Drug: AGN 203818; Drug: AGN 203818; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any other uncontrolled disease
• Pregnant or nursing females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGN 203818 3 mg; Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks	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
Experimental: AGN 203818 20 mg; Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks	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
Experimental: AGN 203818 60 mg; Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks	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
Placebo Comparator: Placebo; Part A: Placebo capsule every 12 hours for 4 weeks	Drug: placebo; Part A: placebo capsule every 12 hours for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Highest-Average-Pain Score at 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).	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at 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.	Week 4
Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at 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.	Week 4
Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)	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.	Baseline, Week 4

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 27, 2007
• First Submitted That Met QC Criteria: February 27, 2007
• First Posted (Estimate): March 1, 2007

Study Record Updates

• Last Update Posted (Estimate): January 20, 2012
• Last Update Submitted That Met QC Criteria: December 16, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 203818-008