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

  Show 25 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: 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 September 30, 2014