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

This study has been terminated.
(Study was terminated due to company decision after Part A. Part B was never conducted)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00441766
First received: February 27, 2007
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: AGN 203818
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Highest-Average-Pain Score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 213
Study Start Date: March 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: AGN 203818 20 mg
Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
Drug: AGN 203818
Part A: 20 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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any other uncontrolled disease
  • Pregnant or nursing females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441766

Locations
United States, California
Orange, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00441766     History of Changes
Other Study ID Numbers: 203818-008
Study First Received: February 27, 2007
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014