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An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in 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. Identifier: NCT00601484
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 7, 2011
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Brief Summary:
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Drug: PF-04383119 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: PF-04383119
PF-04383119 200 mcg/kg IV, single dose

Placebo Comparator: 2 Drug: Placebo
placebo IV, single dose

Primary Outcome Measures :
  1. Change in average daily pain [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ]
  2. Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ]
  3. Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ]
  4. Global response assessment [ Time Frame: 16 weeks ]
  5. Patient-reported treatment impact assessment [ Time Frame: 16 weeks ]
  6. Treatment failures [ Time Frame: 16 weeks ]
  7. Biomarkers [ Time Frame: 16 weeks ]
  8. Safety endpoints [ Time Frame: 16 weeks ]
  9. Pharmacokinetic measures [ Time Frame: 16 weeks ]
  10. Change in average daily pain [ Time Frame: 16 weeks ]
  11. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00601484

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc. Identifier: NCT00601484     History of Changes
Other Study ID Numbers: A4091010
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011
Keywords provided by Pfizer:
Painful Bladder Syndrome, monoclonal antibody
Additional relevant MeSH terms:
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Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs