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
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 April 22, 2014