Clinical trial NCT00601484: An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystitis, Interstitial
Keywords: Painful Bladder Syndrome
monoclonal antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Average Daily Pain Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16
timeFrame: Baseline, Week 2, 4, 10, 16
measure: Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16
timeFrame: Baseline, Week 2, 4, 6, 10, 16
measure: Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16
timeFrame: Week 6, 16
measure: Patient's Global Satisfaction Assessment
timeFrame: Week 6, 16
measure: Patient's Global Preference Assessment at Weeks 6, and 16
timeFrame: Week 6, 16
measure: Patient Willingness to Re-use Medicine Assessment
timeFrame: Week 6, 16
measure: Percentage of Participants Who Use Rescue Medication
timeFrame: Baseline up to Week 16
measure: Ratio of Number of Days Rescue Medication Used
timeFrame: Baseline up to Week 16
measure: Average Number of Doses Per Day of Rescue Medication Used
timeFrame: Baseline up to Week 16
measure: Amount of Rescue Medication Taken Per Day
timeFrame: Baseline up to Week 16
measure: Time to First Dose of Rescue Medication as a Proportion of Total Days in Study
timeFrame: Baseline up to Week 16
measure: Plasma and Urine Total Nerve Growth Factor (NGF) Concentration
timeFrame: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16
measure: Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration
timeFrame: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16
measure: Anti-Proliferative Factor (APF) Urine Concentration
timeFrame: Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examination
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Change From Baseline in Body Weight
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
timeFrame: Baseline up to Week 16
measure: Post-void Residual (PVR) Volume
timeFrame: Baseline, Week 2, 6, 16
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Presence of Anti-Drug Antibody (ADA)
timeFrame: Day 1, Week 4, 6, 16
measure: Plasma Concentration of Tanezumab
timeFrame: 0 hour (pre-dose), 1, 2 hours post-dose on Day 1; and at Week 2, 4, 6, 10, 16
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Glendora
country: United States
facility: Citrus Valley Medical Research Inc.
state: California
city: San Diego
country: United States
facility: SD Uro-Research
state: California
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital, Urogynecology Division
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Middlebury
country: United States
facility: The Connecticut Clinical Research Center, Urology Specialists PC
state: Connecticut
city: Middlebury
country: United States
facility: Waterbury Neurology
state: Connecticut
city: New Britain
country: United States
facility: Connecticut Urological Research at Grove Hill
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: New London
country: United States
facility: Timothy M. Barczak, MD, LLC
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Utica
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Saint Louis
country: United States
facility: Barnes Jewish West County Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University, Division of Urologic Surgery
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research Inc
state: Nebraska
city: New Hyde Park
country: United States
facility: The Arthur Smith Institute for Urology
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Urologic Services PSC, Inc. dba The Urology Group
state: Ohio
city: Bethany
country: United States
facility: Parkhurst Research Organization, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: Triangle Urological Associates
state: Pennsylvania
city: Greer
country: United States
facility: Matrix Research, LLC (Administrative Only)
state: South Carolina
city: Greer
country: United States
facility: The Urology Group
state: South Carolina
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
city: Spokane
country: United States
facility: Northside Internal Medicine
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.