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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381 United States
Contact
1-800-718-1021
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.

NCT00601484
Pfizer
Completed
An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

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An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
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
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Cystitis, Interstitial
  • Drug: PF-04383119
    PF-04383119 200 mcg/kg IV, single dose
  • Drug: Placebo
    placebo IV, single dose
  • Experimental: 1
    Intervention: Drug: PF-04383119
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
April 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00601484
A4091010
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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