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
Results First Received: December 16, 2011  
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
Condition: Irritable Bowel Syndrome
Interventions: Drug: AGN 203818
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AGN 203818 60 mg Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
AGN 203818 20 mg Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
AGN 203818 3 mg Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
Placebo Part A: Placebo capsule every 12 hours for 4 weeks

Participant Flow:   Overall Study
    AGN 203818 60 mg     AGN 203818 20 mg     AGN 203818 3 mg     Placebo  
STARTED     53     53     53     54  
COMPLETED     39     46     44     48  
NOT COMPLETED     14     7     9     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AGN 203818 60 mg Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
AGN 203818 20 mg Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
AGN 203818 3 mg Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
Placebo Part A: Placebo capsule every 12 hours for 4 weeks
Total Total of all reporting groups

Baseline Measures
    AGN 203818 60 mg     AGN 203818 20 mg     AGN 203818 3 mg     Placebo     Total  
Number of Participants  
[units: participants]
  53     53     53     54     213  
Age, Customized  
[units: participants]
         
18 to 64 years     48     48     50     54     200  
>=65 years     5     5     3     0     13  
Gender  
[units: participants]
         
Female     53     53     53     54     213  
Male     0     0     0     0     0  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Highest-Average-Pain Score at Week 4   [ Time Frame: Baseline, Week 4 ]

2.  Secondary:   Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4   [ Time Frame: Week 4 ]

3.  Secondary:   Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4   [ Time Frame: Week 4 ]

4.  Secondary:   Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)   [ Time Frame: Baseline, Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only Part A results are presented; Due to termination of the study, Part B was never conducted.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


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