A Phase 3 Study of Tanezumab for Chronic Low Back Pain

NCT02528253

Last updated date
Study Location
Central Alabama Research
Birmingham, Alabama, 35209, United States
Contact
877-355-1989

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

-Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of
Rheumatology (ACR) criteria.


- Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or
Grade > or=3 radiographic evidence of knee osteoarthritis will be excluded;


- History or radiographic evidence of other diseases that could confound efficacy or
safety assessments (e.g., rheumatoid arthritis).


- History or radiographic evidence of orthopedic conditions that may increase the risk
of, or confound assessment of joint safety conditions during the study.


- Signs and symptoms of clinically significant cardiac disease within 6 months of the
study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly
controlled or untreated hypertension) as defined in the protocol or subjects with any
other cardiovascular illness that in the opinion of the Investigator would render a
subject unsuitable to participate in the study


- History, diagnosis, or signs and symptoms of clinically significant neurological
disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy)
as specified in the protocol


- Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g.,
orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Trial Procedures
Electrocardiogram (ECG)
Physical examination
Keeping a diary
Questionnaire
X-rays
Vital signs and measurements
Urine test
Blood test

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
Brief Summary This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Detailed Description This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56. The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Biological: Placebo to Week 16; tanezumab 5mg SC
    Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
  • Biological: Placebo to Week 16, tanezumab 10 mg SC
    Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
  • Biological: Tanezumab 5 mg SC
    Tanezumab 5 mg SC
  • Biological: Tanezumab 10 mg SC
    Tanezumab 10 mg SC
  • Biological: Tramadol PR oral
    Tramadol PR oral
Study Arms  ICMJE
  • Placebo Comparator: Placebo to Week 16; tanezumab 5 mg SC
    Intervention: Biological: Placebo to Week 16; tanezumab 5mg SC
  • Placebo Comparator: Placebo to Week 16, tanezumab 10 mg SC
    Intervention: Biological: Placebo to Week 16, tanezumab 10 mg SC
  • Experimental: Tanezumab 5 mg SC
    Intervention: Biological: Tanezumab 5 mg SC
  • Experimental: Tanezumab 10 mg SC
    Intervention: Biological: Tanezumab 10 mg SC
  • Active Comparator: Tramadol PR oral
    Intervention: Biological: Tramadol PR oral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2019)
1832
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2015)
1800
Actual Study Completion Date  ICMJE December 20, 2018
Actual Primary Completion Date October 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Chronic low back pain ?3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.

Exclusion Criteria:

--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.

  • Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or Grade > or=3 radiographic evidence of knee osteoarthritis will be excluded;
  • History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
  • History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
  • Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
  • History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
  • Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   France,   Hungary,   Japan,   Korea, Republic of,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02528253
Other Study ID Numbers  ICMJE A4091059
2012-005495-34 ( EudraCT Number )
CLBP SC STUDY ( Other Identifier: Alias Study Number )
A4091059 ( Other Identifier: Pfizer )
TANGO ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP