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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00826514
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : March 25, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Drug: Tanezumab Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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
Study Start Date : March 2009
Primary Completion Date : January 2010
Study Completion Date : March 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: Tanezumab Drug: Tanezumab
Intravenous, 20 mg, single dose.
Placebo Comparator: Placebo Drug: Placebo
Intravenous placebo, single dose


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826514


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00826514     History of Changes
Other Study ID Numbers: A4091019
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: March 25, 2011
Last Verified: March 2011

Keywords provided by Pfizer:
Chronic Prostatis

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