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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Treatments: Drug: Tanezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00826514

PROSTATITIS POC (Other Identifier)

A4091019

2008-004861-25 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

Tanezumab

Experimental group

Treatment:

Drug: Tanezumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo