A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis

This study has been terminated.
(Further recruitment into the study was ceased on 10th December 2009, not attributed to safety. All patients recruited in the study completed all study visits.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00784693
First received: November 3, 2008
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.


Condition Intervention Phase
Endometriosis
Biological: Tanezumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 Endometriosis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in average daily endometriosis pain over the preceding 28 days as measured by an 11-point numeric pain rating scale (NRS) derived from patient daily diary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily endometriosis pain at other time points, measured by NRS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Average endometriosis pain during menstruation, average non-menstrual endometriosis pain, and average pain with intercourse, as measured by NRS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Worst daily endometriosis pain, worst endometriosis pain during menstruation and worst non-menstrual endometriosis pain, as measured by NRS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Patient Questionnaires: Endometriosis symptom severity score (ESSS), Endometriosis Health Profile-30 (EHP-30), Global Response Assessment (GRA) and Patient Reported Treatment Impact (PRTI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety endpoints: Physical examination, ECG, Pregnancy testing, clinical laboratory assessments, anti-tanezumab antibody and adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab Biological: Tanezumab
15 mg IV single dose
Placebo Comparator: Placebo Drug: Placebo
Placebo IV single dose

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-menstrual women with moderate to severe endometriosis. The diagnosis of endometriosis must have been confirmed surgically within the last 8 years.
  • Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). Contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely.

Exclusion Criteria:

  • Previous hysterectomy
  • Surgical treatment for endometriosis within last 6 months.
  • Medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months
  • Current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed).
  • Any history of malignant disease (cancer)
  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: NCT00784693

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Pfizer Investigational Site
San Diego, California, United States, 92108
Pfizer Investigational Site
San Diego, California, United States, 92103
United States, Florida
Pfizer Investigational Site
Boynton Beach, Florida, United States, 33437
Pfizer Investigational Site
Crystal River, Florida, United States, 34429
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66202
Pfizer Investigational Site
Overland Park, Kansas, United States, 66215
United States, Massachusetts
Pfizer Investigational Site
Fall River, Massachusetts, United States, 02720
United States, Michigan
Pfizer Investigational Site
Paw Paw, Michigan, United States, 49079
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68510
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74105
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16602
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37421
Pfizer Investigational Site
East Ridge, Tennessee, United States, 37412
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Houston, Texas, United States, 77079
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98105
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: NCT00784693     History of Changes
Other Study ID Numbers: A4091023
Study First Received: November 3, 2008
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Endometriosis
pain
tanezumab
nerve growth factor
questionnaires

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014