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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00739739
Date of registration: 20/08/2008
Prospective Registration: No
Primary sponsor: Pfizer
Public title: An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
Scientific title: 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: August 2008
Target sample size: 161
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00739739
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Canada Denmark Finland France Germany United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
Painful Bladder Syndrome
Intervention(s)
Drug: PD 0299685 at 30mg BID
Drug: PD 0299685 at 15mg BID
Drug: placebo for PD 0299685
Primary Outcome(s)
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. [Time Frame: 12 WEEKS]
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). [Time Frame: 12 WEEKS]
Secondary Outcome(s)
ECG [Time Frame: 14 Weeks]
Clinical laboratory tests [Time Frame: 14 Weeks]
Pelvic pain Urgency Frequency score (PUF) [Time Frame: 12 weeks]
ICSI at other time points [Time Frame: 12 weeks]
Interstitial Cystitis Problem Index (ICPI) [Time Frame: 12 weeks]
Physical examination [Time Frame: 14 Weeks]
Columbia-Suicide Severity Rating Scale (C-SSRS) [Time Frame: 15 Weeks]
Epworth Sleepiness Scale (ESS) [Time Frame: 12 Weeks]
Residual urine volume measurement [Time Frame: 14 Weeks]
Sleep disturbance and sexual activity pain. [Time Frame: 12 Weeks]
Vital signs and weight [Time Frame: 15 Weeks]
Adverse events [Time Frame: 15 Weeks]
Global Response assessment (GRA) [Time Frame: 12 Weeks]
Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [Time Frame: 12 weeks]
Treatment failures [Time Frame: 12 Weeks]
Average and worst daily pain score at other time points as measured by an 11-point NRS. [Time Frame: 12 Weeks]
Patient Reported Treatment Impact (PRTI) [Time Frame: 12 Weeks]
Secondary ID(s)
A4291043
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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