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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601484
First Posted: January 28, 2008
Last Update Posted: January 7, 2011
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.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

Condition Intervention Phase
Cystitis, Interstitial Drug: PF-04383119 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 65
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-04383119
PF-04383119 200 mcg/kg IV, single dose
Placebo Comparator: 2 Drug: Placebo
placebo IV, single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00601484


  Show 29 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00601484     History of Changes
Other Study ID Numbers: A4091010
First Submitted: January 15, 2008
First Posted: January 28, 2008
Last Update Posted: January 7, 2011
Last Verified: January 2011

Keywords provided by Pfizer:
Painful Bladder Syndrome, monoclonal antibody

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases