An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00601484
First received: January 15, 2008
Last updated: January 4, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystitis, Interstitial |
Drug: PF-04383119 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof Of Concept Study Evaluating The Efficacy And Safety Of PF-04383119 For The Treatment Of Pain Associated With Interstitial Cystitis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in average daily pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Global response assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Patient-reported treatment impact assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Biomarkers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Safety endpoints [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetic measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in average daily pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | March 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: PF-04383119
PF-04383119 200 mcg/kg IV, single dose
|
| Placebo Comparator: 2 |
Drug: Placebo
placebo IV, single dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female adults at least 18 years of age;
- Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.
Exclusion Criteria:
- Less than 6 months since onset of interstitial cystitis symptoms;
- History of recurrent urinary tract infections, or genitourinary cancer;
- History of hepatitis B, C or human immunodeficiency virus (HIV);
- Use of certain drugs given into the bladder up to 1 month prior to study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601484
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Hide Study LocationsLocations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Peoria, Arizona, United States, 85381 | |
| United States, California | |
| Pfizer Investigational Site | |
| Fresno, California, United States, 93710 | |
| Pfizer Investigational Site | |
| Glendora, California, United States, 91741 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Boulder, Colorado, United States, 80304 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Hartford, Connecticut, United States, 06041 | |
| Pfizer Investigational Site | |
| Hartford, Connecticut, United States, 06106 | |
| Pfizer Investigational Site | |
| Middlebury, Connecticut, United States, 06762 | |
| Pfizer Investigational Site | |
| New Britain, Connecticut, United States, 06052 | |
| Pfizer Investigational Site | |
| New London, Connecticut, United States, 06320 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Jeffersonville, Indiana, United States, 47130 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71106 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Owings Mills, Maryland, United States, 21117 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Royal Oak, Michigan, United States, 48073 | |
| Pfizer Investigational Site | |
| Troy, Michigan, United States, 48084 | |
| Pfizer Investigational Site | |
| Utica, Michigan, United States, 48313 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New Hyde Park, New York, United States, 11040 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14627 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Greensboro, North Carolina, United States, 27403 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45212 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Bethany, Oklahoma, United States, 73008 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Greer, South Carolina, United States, 29650 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Mountlake, Washington, United States, 98043 | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99208 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00601484 History of Changes |
| Other Study ID Numbers: | A4091010 |
| Study First Received: | January 15, 2008 |
| Last Updated: | January 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Painful Bladder Syndrome, monoclonal antibody |
Additional relevant MeSH terms:
|
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013