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

February 27, 2007
December 16, 2011
March 2007
February 2008   (final data collection date for primary outcome measure)
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).
Reduction in daily pain scores
Complete list of historical versions of study NCT00441766 on ClinicalTrials.gov Archive Site
  • 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.
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Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
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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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • 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
  • Drug: placebo
    Part A: placebo capsule every 12 hours for 4 weeks
  • Experimental: AGN 203818 3 mg
    Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks
    Intervention: Drug: AGN 203818
  • Experimental: AGN 203818 20 mg
    Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
    Intervention: Drug: AGN 203818
  • Experimental: AGN 203818 60 mg
    Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
    Intervention: Drug: AGN 203818
  • Placebo Comparator: Placebo
    Part A: Placebo capsule every 12 hours for 4 weeks
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
213
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any other uncontrolled disease
  • Pregnant or nursing females
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00441766
203818-008
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP