Clinical trial NCT00784693: A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
pain
tanezumab
nerve growth factor
questionnaires
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16
timeFrame: Weeks 4, 12, and 16
measure: Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8
timeFrame: Baseline and Week 8
measure: Global Response Assessment (GRA) at Week 8
timeFrame: Week 8
measure: Participant Global Satisfaction at Week 8
timeFrame: Week 8
measure: Participant Global Preference at Week 8
timeFrame: Week 8
measure: Participant Willingness to Re-use Study Medication
timeFrame: Week 8
measure: Plasma Nerve Growth Factor (NGF) Concentration
timeFrame: Day 1, Week 8, and Week 16 (End of Treatment)
measure: Amount of Rescue Medication Used
timeFrame: Baseline, Weeks 4, 8, 12, and 16
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 113 days after last dose of study medication
measure: Number of Participants With New or Worsened Neurological Examinations
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With Anti-Drug Antibody (ADA)
timeFrame: Day 1 (pre-dose), Weeks 2, 4, 8, and 16
measure: Number of Participants With Positive Urine or Serum Pregnancy Test
timeFrame: Screening, Weeks 2, 4, 8, 12, and Early termination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Bay Area Physicians for Women
state: Alabama
city: Mobile
country: United States
facility: Springhill Medical Center
state: Alabama
city: Mobile
country: United States
facility: Wilmax Clinical Research
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clnical Research
state: Florida
city: West Palm Beach
country: United States
facility: Advanced Women's Healthcare
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Overland Park
country: United States
facility: Radiant Research
state: Kansas
city: Overland Park
country: United States
facility: Women's Healthcare Group
state: Kansas
city: Fall River
country: United States
facility: N.E.C.C.R, Fall River LLC
state: Massachusetts
city: Paw Paw
country: United States
facility: Beyer Research - Women's Health Care Specialists, PC
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Kernersville
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Tulsa
country: United States
facility: Planned Parenthood of Arkansas and Eastern Oklahoma
state: Oklahoma
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Group, Department of OB/GYN
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: East Ridge
country: United States
facility: Whitaker's Women Care
state: Tennessee
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Houston
country: United States
facility: Allon Health Care
state: Texas
city: Salt Lake City
country: United States
facility: Old Farm Obstetrics and Gynecology
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: