Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis

This study has been terminated.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00380783

First received: September 22, 2006

Last updated: May 27, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 22, 2006
Last Updated Date	May 27, 2011
Start Date ^ICMJE	October 2006
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 22, 2006)	Reduction in daily pain scores
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00380783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis
Official Title ^ICMJE
Brief Summary	This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with painful bladder syndrome/interstitial cystitis
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Cystitis, Interstitial
Intervention ^ICMJE	Drug: AGN 203818
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	2
Completion Date	March 2007
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of painful bladder syndrome/interstitial cystitis Moderate or severe bladder pain Exclusion Criteria: Any other uncontrolled disease Pregnant or nursing females
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00380783
Other Study ID Numbers ^ICMJE	203818-005
Has Data Monitoring Committee
Responsible Party	Therapeutic Area Head, Allergan, Inc
Study Sponsor ^ICMJE	Allergan
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Allergan
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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