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

April 5, 2021 updated by: Pfizer

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

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

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36608
        • WILMAX Clinical Research
      • Mobile, Alabama, United States, 36608
        • Springhill Medical Center
      • Mobile, Alabama, United States, 36608
        • Bay Area Physicians for Women
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research - Tucson
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Diego, California, United States, 92103
        • Genesis Center for Clinical Research
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clnical Research
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
      • West Palm Beach, Florida, United States, 33409
        • Advanced Women's Healthcare
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Mount Vernon Clinical Research
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Radiant Research
      • Overland Park, Kansas, United States, 66215
        • Women's Healthcare Group
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • N.E.C.C.R, Fall River LLC
    • Michigan
      • Paw Paw, Michigan, United States, 49079
        • Beyer Research - Women's Health Care Specialists, PC
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln, PC
    • North Carolina
      • Kernersville, North Carolina, United States, 27284
        • Lyndhurst Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Columbus Center for Women's Health Research
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74105
        • Planned Parenthood of Arkansas and Eastern Oklahoma
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Allegheny Pain Management
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System University Medical Group, Department of OB/GYN
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
      • East Ridge, Tennessee, United States, 37412
        • Whitaker's Women Care
    • Texas
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc.
      • Houston, Texas, United States, 77079
        • Allon Health Care
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
      • Salt Lake City, Utah, United States, 84107
        • Old Farm Obstetrics and Gynecology
    • Washington
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo IV single dose
Experimental: Tanezumab
15 mg IV single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
Time Frame: Baseline, Week 8
Participants assessed daily endometriosis pain on an 11-point Numeric Rating Scale (NRS) of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16
Time Frame: Weeks 4, 12, and 16
Participants assessed daily endometriosis pain on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Weeks 4, 12, and 16
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Endometriosis pain during menstruation was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain.
Baseline, Weeks 4, 8, 12, and 16
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Non-menstrual endometriosis pain was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) on the non-menstrual days for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain.
Baseline, Weeks 4, 8, 12, and 16
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Participants assessed worst endometriosis pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Baseline, Weeks 4, 8, 12, and 16
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Participants assessed worst endometriosis pain during menstruation in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period preceding the post-baseline visit.
Baseline, Weeks 4, 8, 12, and 16
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Participants assessed worst endometriosis non-menstrual pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period preceding the post-baseline visit.
Baseline, Weeks 4, 8, 12, and 16
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Pain related to sexual intercourse was defined as the discomfort or pain that may occur during or after sexual intercourse with vaginal penetration. Participants assessed pain during or after sexual intercourse on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
Baseline, Weeks 4, 8, 12, and 16
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Investigator assessed the severity of the dysmenorrhea (menstrual pain), pelvic pain and dyspareunia (painful sexual intercourse) experienced by participants occurring during the most recent menstrual cycle on a 4-point scale, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Total score was calculated as a sum of the individual pain scores for dysmenorrhea, dyspareunia and pelvic pain. The total score range: 0 (no pain) to 9 (worst possible pain).
Baseline, Weeks 4, 8, 12, and 16
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8
Time Frame: Baseline and Week 8
EHP-30 is a validated quality of life (QoL) scale assessing emotional, physical and sexual function. EHP-30 consists of 30 items that assess the frequency of physical and mental manifestations of endometriosis during the previous 4 weeks on a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always).. Scores for 6 domains (pain, control and powerlessness, emotional well-being, social support, self image, and sexual intercourse) were obtained as a sum of all relevant item scores and transformed to a 0 to 100 score range. Each domain score ranges from 0 (best possible health status) to 100 (worst possible health status).
Baseline and Week 8
Global Response Assessment (GRA) at Week 8
Time Frame: Week 8
GRA questionnaire is a 7-point symmetric scale which measures participant-reported overall response to treatment compared to baseline as 1 of the following possible responses: markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved, and markedly improved. Number of participants with each response is reported.
Week 8
Participant Global Satisfaction at Week 8
Time Frame: Week 8
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant's response is rated on a 5-point scale where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. Number of participants with each response is reported.
Week 8
Participant Global Preference at Week 8
Time Frame: Week 8
Participant global preference is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant reported previous treatment under following categories: hormonal contraceptive, painkiller, and hormone treatment by injection, hormone treatment by tablet, surgery, and no treatment. Participant preference was assessed using following categories: definitely prefer study medication, slightly prefer study medication, no preference, slightly prefer previous treatment, and definitely prefer previous treatment. Number of participants under each of the categories is reported. For previous treatment, a single participant may be represented in more than 1 category.
Week 8
Participant Willingness to Re-use Study Medication
Time Frame: Week 8
Participant willingness to re-use study medication is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, definitely would not want to re-use.
Week 8
Plasma Nerve Growth Factor (NGF) Concentration
Time Frame: Day 1, Week 8, and Week 16 (End of Treatment)
Day 1, Week 8, and Week 16 (End of Treatment)
Amount of Rescue Medication Used
Time Frame: Baseline, Weeks 4, 8, 12, and 16
Mean amount of daily rescue medication (acetaminophen 500 mg tablet/capsule) taken for endometriosis associated pain (in mg) was assessed.
Baseline, Weeks 4, 8, 12, and 16
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 113 days after last dose of study medication
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 113 days after last dose that were absent before treatment or worsened relative to pre-treatment state.
Baseline up to 113 days after last dose of study medication
Number of Participants With New or Worsened Neurological Examinations
Time Frame: Weeks 2, 4, 8, 12, and 16
A neurological evaluation was performed by a consulting neurologist if adverse events suggested new or worsening peripheral neuropathy with respect to baseline or any adverse event of abnormal peripheral sensation was recorded. A neurological evaluation was done as soon as the above signs and symptoms were known, preferably within 7 days of becoming aware of such problems if possible. Neurological evaluation was done using Neuropathy Impairment Score (NIS) by investigator. Neurologic examination assessment included strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes. Abnormality was judged by the investigator.
Weeks 2, 4, 8, 12, and 16
Number of Participants With Anti-Drug Antibody (ADA)
Time Frame: Day 1 (pre-dose), Weeks 2, 4, 8, and 16
Serum samples were analyzed for the presence or absence of anti-tanezumab antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA).
Day 1 (pre-dose), Weeks 2, 4, 8, and 16
Number of Participants With Positive Urine or Serum Pregnancy Test
Time Frame: Screening, Weeks 2, 4, 8, 12, and Early termination
Screening, Weeks 2, 4, 8, 12, and Early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2008

Primary Completion (Actual)

January 27, 2010

Study Completion (Actual)

April 5, 2010

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 4, 2008

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • A4091023
  • ENDOMETRIOSIS POC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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