An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

NCT00601484

Last updated date
Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Cystitis
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

- Male and female adults at least 18 years of age;

- Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

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


- Less than 6 months since onset of interstitial cystitis symptoms;


- History of recurrent urinary tract infections, or genitourinary cancer;


- History of hepatitis B, C or human immunodeficiency virus (HIV);


- Use of certain drugs given into the bladder up to 1 month prior to study entry.

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
Official Title  ICMJE A Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof Of Concept Study Evaluating The Efficacy And Safety Of PF-04383119 For The Treatment Of Pain Associated With Interstitial Cystitis
Brief Summary The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.
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 Cystitis, Interstitial
Intervention  ICMJE
  • Drug: PF-04383119
    PF-04383119 200 mcg/kg IV, single dose
  • Drug: Placebo
    placebo IV, single dose
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: PF-04383119
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7:CD013325. doi: 10.1002/14651858.CD013325.pub2.

*   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: May 18, 2009)
65
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
64
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female adults at least 18 years of age;
  • Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion Criteria:

  • Less than 6 months since onset of interstitial cystitis symptoms;
  • History of recurrent urinary tract infections, or genitourinary cancer;
  • History of hepatitis B, C or human immunodeficiency virus (HIV);
  • 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00601484
Other Study ID Numbers  ICMJE A4091010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials 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 January 2011

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