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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00601484
First received: January 15, 2008
Last updated: January 4, 2011
Last verified: January 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Global response assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Patient-reported treatment impact assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety endpoints [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in average daily pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601484

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00601484     History of Changes
Other Study ID Numbers: A4091010
Study First Received: January 15, 2008
Last Updated: January 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Painful Bladder Syndrome, monoclonal antibody

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

ClinicalTrials.gov processed this record on October 21, 2014