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An Effectiveness and Safety Study of PD 0299685 for the Treatment of Symptoms Associated With Interstitial Cystitis
This study is currently recruiting participants.
Study NCT00739739   Information provided by Pfizer
First Received: August 20, 2008   Last Updated: May 11, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

August 20, 2008
May 11, 2009
August 2008
  • Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]
  • Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739739 on ClinicalTrials.gov Archive Site
  • Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ICSI at other time points [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Vital signs and weight [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Residual urine volume measurement [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Global Response assessment (GRA) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Treatment failures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Average and worst daily pain score at other time points as measured by an 11-point NRS. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Sleep disturbance and sexual activity pain. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ICSI at other time points, Interstitial Cytstitis Problem Index (ICPI), and Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Physical examination, vital signs and weight, ECG, residual urine volume measurement, Clinical laboratory tests • Epworth Sleepiness Scale (ESS). • Columbia-Suicide Severity Rating Scale (C-SSRS). • Adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • Average and worst daily pain score at other time points as measured by an 11-point NRS. Sleep disturbance and sexual activity pain. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Response assessment (GRA), Patient Reported Treatment Impact (PRTI), and treatment failures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
 
An Effectiveness and Safety Study of PD 0299685 for the Treatment of Symptoms Associated With Interstitial Cystitis
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.

The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
  • Interstitial Cystitis
  • Painful Bladder Syndrome
  • Drug: PD 0299685 at 15mg BID
  • Drug: PD 0299685 at 30mg BID
  • Drug: placebo for PD 0299685
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
129
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Canada,   Denmark,   Finland,   France,   Germany
 
 
NCT00739739
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
 
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.