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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00784693
First received: November 3, 2008
Last updated: April 22, 2011
Last verified: April 2011
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784693
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Hide Study LocationsLocations
| 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 May 19, 2013