An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis

NCT ID: NCT00826514

Last Updated: 2021-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-25

Study Completion Date

2010-03-17

Brief Summary

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The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.

Detailed Description

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Conditions

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Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tanezumab

Group Type EXPERIMENTAL

Tanezumab

Intervention Type DRUG

Intravenous, 20 mg, single dose.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous placebo, single dose

Interventions

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Tanezumab

Intravenous, 20 mg, single dose.

Intervention Type DRUG

Placebo

Intravenous placebo, single dose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Alabama Research Center, LLC

Birmingham, Alabama, United States

Site Status

The Kirklin Clinic

Birmingham, Alabama, United States

Site Status

University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Valley Urologic Associates

Goodyear, Arizona, United States

Site Status

Dedicated Clinical Research

Litchfield Park, Arizona, United States

Site Status

Clinical Innovations, Inc.

Costa Mesa, California, United States

Site Status

Citrus Valley Medical Research Inc.

Glendora, California, United States

Site Status

Atlantic Urological Medical Group Incorporated

Long Beach, California, United States

Site Status

Orange Coast Urology

Newport Beach, California, United States

Site Status

Los Angeles Infertility and Prostatitis Medical Group

Santa Monica, California, United States

Site Status

Specialists in Urology

Bonita Springs, Florida, United States

Site Status

Specialists in Urology

Naples, Florida, United States

Site Status

Pinellas Urology, Inc.

St. Petersburg, Florida, United States

Site Status

Regional Urology, LLC

Shreveport, Louisiana, United States

Site Status

Quality Clinical Research

Omaha, Nebraska, United States

Site Status

Hudson Valley Urology, PC

Kingston, New York, United States

Site Status

University Urology Associates

New York, New York, United States

Site Status

Hudson Valley Urology, PC

Poughkeepsie, New York, United States

Site Status

Tri-State Urologic Services PSC, Inc. dba The Urology Group

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Temple University of the Commonwealth System of Higher Education

Philadelphia, Pennsylvania, United States

Site Status

University Urology

Knoxville, Tennessee, United States

Site Status

Volunteer Research Group

Knoxville, Tennessee, United States

Site Status

Prostate Cancer Centre / Urology Research

Calgary, Alberta, Canada

Site Status

Office of Dr. Nazmuddin Merali

Victoria, British Columbia, Canada

Site Status

Can-Med Clinical Research Inc.

Victoria, British Columbia, Canada

Site Status

PJ Pommerville Inc.

Victoria, British Columbia, Canada

Site Status

Dr. Steinhoff Clinical Research

Victoria, British Columbia, Canada

Site Status

Manitoba Prostate Centre

Winnipeg, Manitoba, Canada

Site Status

The Male/Female Health and Research Centre

Barrie, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Centre for Applied Urological Research

Kingston, Ontario, Canada

Site Status

Urology Associates / Urologic Medical Research

Kitchener, Ontario, Canada

Site Status

The Male Health Centre

Toronto, Ontario, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Hopital Edouard Herriot

Lyon, , France

Site Status

Centre Hospitalier Universitaire de NANTES (CHU)

Nantes, , France

Site Status

CHU de Nîmes - Hôpital CAREMEAU

Nîmes, , France

Site Status

Hopital TENON

Paris, , France

Site Status

Hopital Rothschild

Paris, , France

Site Status

Capio Citykliniken AB

Lund, , Sweden

Site Status

Skaraborgs Sjukhus, FoU-centrum och urologkliniken

Skövde, , Sweden

Site Status

Universitaetsspital Basel, Urologische Klinik

Basel, , Switzerland

Site Status

Klinik und Poliklinik fuer Urologie, Inselspital

Bern, , Switzerland

Site Status

Countries

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United States Canada France Sweden Switzerland

Related Links

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Other Identifiers

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2008-004861-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PROSTATITIS POC

Identifier Type: OTHER

Identifier Source: secondary_id

A4091019

Identifier Type: -

Identifier Source: org_study_id

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