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An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00739739
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 20, 2008
First Posted Date  ICMJE August 22, 2008
Last Update Posted Date March 28, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
  • Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). [ Time Frame: 12 WEEKS ]
  • Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. [ Time Frame: 12 WEEKS ]
Change History Complete list of historical versions of study NCT00739739 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2009)
  • Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ]
  • ICSI at other time points [ Time Frame: 12 weeks ]
  • Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 12 weeks ]
  • Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 12 Weeks ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 Weeks ]
  • Adverse events [ Time Frame: 15 Weeks ]
  • Physical examination [ Time Frame: 14 Weeks ]
  • Vital signs and weight [ Time Frame: 15 Weeks ]
  • ECG [ Time Frame: 14 Weeks ]
  • Residual urine volume measurement [ Time Frame: 14 Weeks ]
  • Global Response assessment (GRA) [ Time Frame: 12 Weeks ]
  • Patient Reported Treatment Impact (PRTI) [ 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 ]
  • Sleep disturbance and sexual activity pain. [ Time Frame: 12 Weeks ]
  • Clinical laboratory tests [ Time Frame: 14 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2008)
  • Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ]
  • ICSI at other time points, Interstitial Cytstitis Problem Index (ICPI), and Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 12 weeks ]
  • 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 ]
  • Global Response assessment (GRA), Patient Reported Treatment Impact (PRTI), and treatment failures [ Time Frame: 12 Weeks ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Cystitis
  • Painful Bladder Syndrome
Intervention  ICMJE
  • Drug: PD 0299685 at 15mg BID
    5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
  • Drug: PD 0299685 at 30mg BID
    10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
  • Drug: placebo for PD 0299685
    Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Study Arms  ICMJE
  • Experimental: PD 0299685 15mg
    Intervention: Drug: PD 0299685 at 15mg BID
  • Experimental: PD 0299685 30mg
    Intervention: Drug: PD 0299685 at 30mg BID
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo for PD 0299685
Publications * Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel α2δ ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2011)
161
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2008)
129
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Finland,   France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00739739
Other Study ID Numbers  ICMJE A4291043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP