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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00601484 |
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Date of registration:
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15/01/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
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Scientific title:
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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 |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00601484 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystitis, Interstitial
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Intervention(s)
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Drug: Placebo
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Drug: PF-04383119
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Primary Outcome(s)
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Change in average daily pain
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Biomarkers
[Time Frame: 16 weeks]
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Patient-reported treatment impact assessment
[Time Frame: 16 weeks]
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Change in average daily pain
[Time Frame: 16 weeks]
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Pharmacokinetic measures
[Time Frame: 16 weeks]
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Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score
[Time Frame: 16 weeks]
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Global response assessment
[Time Frame: 16 weeks]
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Safety endpoints
[Time Frame: 16 weeks]
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Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score
[Time Frame: 16 weeks]
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Treatment failures
[Time Frame: 16 weeks]
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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]
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Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score
[Time Frame: 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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