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

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ClinicalTrials.gov Identifier: NCT00601484
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
Pfizer

January 15, 2008
January 28, 2008
January 7, 2011
March 2008
April 2009   (Final data collection date for primary outcome measure)
Change in average daily pain [ Time Frame: 6 weeks ]
Same as current
Complete list of historical versions of study NCT00601484 on ClinicalTrials.gov Archive Site
  • Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ]
  • Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ]
  • Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ]
  • Global response assessment [ Time Frame: 16 weeks ]
  • Patient-reported treatment impact assessment [ Time Frame: 16 weeks ]
  • Treatment failures [ Time Frame: 16 weeks ]
  • Biomarkers [ Time Frame: 16 weeks ]
  • Safety endpoints [ Time Frame: 16 weeks ]
  • Pharmacokinetic measures [ Time Frame: 16 weeks ]
  • Change in average daily pain [ Time Frame: 16 weeks ]
  • Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ]
  • Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ]
  • Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ]
  • Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ]
  • Global response assessment [ Time Frame: 16 weeks ]
  • Patient-reported treatment impact assessment [ Time Frame: 16 weeks ]
  • Treatment failures [ Time Frame: 16 weeks ]
  • Biomarkers [ Time Frame: 16 weeks ]
  • Safety endpoints [ Time Frame: 16 weeks ]
  • Pharmacokinetic measures [ Time Frame: 16 weeks ]
  • Change in average daily pain [ Time Frame: 16 weeks ]
  • Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
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
64
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, Older Adult)
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