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

NCT00739739

Last updated date
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Cystitis, Painful Bladder Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Interstitial Cystitis, Painful Bladder SyndromeAn Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
NCT00739739
  1. Mobile, Alabama
  2. Goodyear, Arizona
  3. Litchfield Park, Arizona
  4. Phoenix, Arizona
  5. Glendora, California
  6. San Diego, California
  7. Farmington, Connecticut
  8. Orlando, Florida
  9. Jeffersonville, Indiana
  10. Shreveport, Louisiana
  11. Brighton, Massachusetts
  12. Watertown, Massachusetts
  13. Garden City, New York
  14. Poughkeepsie, New York
  15. Burlington, North Carolina
  16. Cincinnati, Ohio
  17. West Chester, Ohio
  18. Bethany, Oklahoma
  19. State College, Pennsylvania
  20. Charleston, South Carolina
  21. Mt. Pleasant, South Carolina
  22. Nashville, Tennessee
  23. Spokane, Washington
  24. Victoria, British Columbia
  25. Barrie, Ontario
  26. Kingston, Ontario
  27. Kingston, Ontario
  28. Kitchener, Ontario
  29. Toronto, Ontario
  30. Sherbrooke, Quebec
  31. Herlev,
  32. Helsinki,
  33. Kouvola,
  34. OYS,
  35. Seinajoki,
  36. Tampere,
  37. Lyon Cedex 03,
  38. Nantes Cedex 1,
  39. Nimes Cedex 9,
  40. Paris,
  41. Rennes Cedex 9,
  42. Strasbourg,
  43. Homburg,
  44. Muenchen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 ?2? 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 CenterPfizer
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