This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: January 21, 2009
Last updated: March 14, 2011
Last verified: March 2011
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.

Condition Intervention Phase
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Drug: Tanezumab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in daily average pain [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Change in urinary diary variables of daytime and nightime frequency, urgency episodes and pain associated with urinary events. [ Time Frame: 16 weeks ]
  • Change in ejaculatory pain score and sleep disturbance score. [ Time Frame: 16 weeks ]
  • Safety endpoints, such as adverse events, laboratory tests, ECG, and residual urine measurement. [ Time Frame: 16 weeks ]
  • Change in daily worst pain [ Time Frame: 16 weeks ]
  • Change in Chronic Prostatitis Symptom Index (CPSI) [ Time Frame: 16 weeks ]
  • Global Response Assessment (GRA) [ Time Frame: 16 weeks ]
  • Patient Reported Treatment Index (PRTI) [ Time Frame: 16 weeks ]
  • Treatment failures [ Time Frame: 16 weeks ]

Enrollment: 62
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab Drug: Tanezumab
Intravenous, 20 mg, single dose.
Placebo Comparator: Placebo Drug: Placebo
Intravenous placebo, single dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00826514

  Show 42 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00826514     History of Changes
Other Study ID Numbers: A4091019
Study First Received: January 21, 2009
Last Updated: March 14, 2011

Keywords provided by Pfizer:
Chronic Prostatis

Additional relevant MeSH terms:
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male processed this record on August 18, 2017