Clinical trial NCT00826514: An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
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 TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH CHRONIC ABACTERIAL PROSTATITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Chronic Prostatis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 62
Sex: MALE
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 tanezumab is effective in the treatment of pain associated with chronic prostatitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic prostatitis
* Male adults at least 18 years of age
* Moderate to severe chronic prostatitis, with an average pain score above a pre-defined level
* To use contraception.

Exclusion Criteria:

* History of symptoms for less than 3 of the last 6 months
* History of recurrent urinary tract infections, or genito-urinary cancer
* Use of finasteride or dutasteride within 6 months.
* History of hepatitis B, C or human immunodeficiency virus (HIV)

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 Weeks 2, 4, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 8, 10, and 16
measure: Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Week 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Mean Urinary Event Pain Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Mean Sleep Disturbance Score Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Change From Baseline in Mean Pain Score Associated With Ejaculation Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, and 16
measure: Number of Participants With Global Response Assessment (GRA)
timeFrame: Week 6 and 16
measure: Patient Global Satisfaction Assessment
timeFrame: Week 6 and 16
measure: Participant Global Preference
timeFrame: Week 6 and 16
measure: Patient Willingness to Re-use Medicine
timeFrame: Week 6 and 16
measure: Percentage of Participants Who Received Rescue Medication
timeFrame: Weeks 2, 4, 6, 8, 10, and 16
measure: Amount of Rescue Medication Taken
timeFrame: Weeks 2, 4, 6, 8, 10, and 16
measure: Serum and Urine Nerve Growth Factor (NGF) Levels
timeFrame: Day 1 (1 hour pre-dose), Weeks 2, 6, 10, and 16
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Neurological Examination Abnormalities
timeFrame: Baseline up to Week 16
measure: Post-void Residual (PVR) Volume
timeFrame: Baseline, Weeks 2, 6, and 16
measure: Number of Participants With Anti-Drug Antibody (ADA)
timeFrame: Day 1 (1 hour pre-dose), Weeks 2, 6, and 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Goodyear
country: United States
facility: Valley Urologic Associates
state: Arizona
city: Litchfield Park
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Glendora
country: United States
facility: Citrus Valley Medical Research Inc.
state: California
city: Long Beach
country: United States
facility: Atlantic Urological Medical Group Incorporated
state: California
city: Newport Beach
country: United States
facility: Orange Coast Urology
state: California
city: Santa Monica
country: United States
facility: Los Angeles Infertility and Prostatitis Medical Group
state: California
city: Bonita Springs
country: United States
facility: Specialists in Urology
state: Florida
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Kingston
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Cincinnati
country: United States
facility: Tri-State Urologic Services PSC, Inc. dba The Urology Group
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University of the Commonwealth System of Higher Education
state: Pennsylvania
city: Knoxville
country: United States
facility: University Urology
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Calgary
country: Canada
facility: Prostate Cancer Centre / Urology Research
state: Alberta
city: Victoria
country: Canada
facility: Office of Dr. Nazmuddin Merali
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Victoria
country: Canada
facility: PJ Pommerville Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Steinhoff Clinical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Prostate Centre
state: Manitoba
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates / Urologic Medical Research
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de NANTES (CHU)
city: Nimes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital CAREMEAU
city: Paris cedex 12
country: France
facility: Hopital Rothschild
city: Paris
country: France
facility: Hopital TENON
city: Lund
country: Sweden
facility: Capio Citykliniken AB
city: Skovde
country: Sweden
facility: Skaraborgs Sjukhus, FoU-centrum och urologkliniken
city: Basel
country: Switzerland
facility: Universitaetsspital Basel, Urologische Klinik
city: Bern
country: Switzerland
facility: Klinik und Poliklinik fuer Urologie, Inselspital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: