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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:
ClinicalTrials.gov Identifier:
NCT00441766
First Posted: March 1, 2007
Last Update Posted: January 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441766


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00441766     History of Changes
Other Study ID Numbers: 203818-008
First Submitted: February 27, 2007
First Posted: March 1, 2007
Results First Submitted: December 16, 2011
Results First Posted: January 20, 2012
Last Update Posted: January 20, 2012
Last Verified: December 2011

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