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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00739739 |
Date of registration:
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20/08/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
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Scientific title:
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A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome. |
Date of first enrolment:
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August 2008 |
Target sample size:
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161 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00739739 |
Study type:
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Interventional |
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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Canada
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Denmark
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Finland
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France
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Germany
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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 |
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:
- Men and women over 18 years of age with moderate to severe interstitial cystitis
defined by pain score.
- Women must not be pregnant or lactating, They may be post-menopausal, surgically
sterilized or using an appropriate method of contraception.
Exclusion Criteria:
- History of interstitial cystitis less than 6 months
- History of current or recurrent urinary tract infections, or genitourinary cancer
- Any previous urinary diversion procedure with or without bladder removal, bladder
augmentation
- 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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Interstitial Cystitis
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Painful Bladder Syndrome
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Intervention(s)
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Drug: PD 0299685 at 30mg BID
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Drug: PD 0299685 at 15mg BID
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Drug: placebo for PD 0299685
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Primary Outcome(s)
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Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
[Time Frame: 12 WEEKS]
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Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
[Time Frame: 12 WEEKS]
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Secondary Outcome(s)
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ECG
[Time Frame: 14 Weeks]
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Clinical laboratory tests
[Time Frame: 14 Weeks]
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Pelvic pain Urgency Frequency score (PUF)
[Time Frame: 12 weeks]
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ICSI at other time points
[Time Frame: 12 weeks]
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Interstitial Cystitis Problem Index (ICPI)
[Time Frame: 12 weeks]
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Physical examination
[Time Frame: 14 Weeks]
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Columbia-Suicide Severity Rating Scale (C-SSRS)
[Time Frame: 15 Weeks]
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Epworth Sleepiness Scale (ESS)
[Time Frame: 12 Weeks]
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Residual urine volume measurement
[Time Frame: 14 Weeks]
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Sleep disturbance and sexual activity pain.
[Time Frame: 12 Weeks]
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Vital signs and weight
[Time Frame: 15 Weeks]
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Adverse events
[Time Frame: 15 Weeks]
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Global Response assessment (GRA)
[Time Frame: 12 Weeks]
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Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
[Time Frame: 12 weeks]
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Treatment failures
[Time Frame: 12 Weeks]
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Average and worst daily pain score at other time points as measured by an 11-point NRS.
[Time Frame: 12 Weeks]
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Patient Reported Treatment Impact (PRTI)
[Time Frame: 12 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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