Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00826514
First received: January 21, 2009
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in daily average pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in ejaculatory pain score and sleep disturbance score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety endpoints, such as adverse events, laboratory tests, ECG, and residual urine measurement. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Change in daily worst pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in Chronic Prostatitis Symptom Index (CPSI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Global Response Assessment (GRA) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Patient Reported Treatment Index (PRTI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT00826514

  Show 42 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00826514     History of Changes
Other Study ID Numbers: A4091019
Study First Received: January 21, 2009
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Chronic Prostatis

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Genital Diseases, Male
Pain
Prostatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014