Back to resultsSafety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis
Primary Purpose
Cystitis, Interstitial
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN 203818
Sponsored by
About this trial
This is an interventional treatment trial for Cystitis, Interstitial
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of painful bladder syndrome/interstitial cystitis
- Moderate or severe bladder pain
Exclusion Criteria:
- Any other uncontrolled disease
- Pregnant or nursing females
Sites / Locations
Outcomes
Primary Outcome Measures
Reduction in daily pain scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00380783
Brief Title
Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Primary Outcome Measure Information:
Title
Reduction in daily pain scores
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of painful bladder syndrome/interstitial cystitis
Moderate or severe bladder pain
Exclusion Criteria:
Any other uncontrolled disease
Pregnant or nursing females
Facility Information:
City
Oklahoma City
State/Province
Oklahoma
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis
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