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A Phase 3 Study of Tanezumab for Chronic Low Back Pain (TANGO)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Pfizer
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02528253
First received: August 11, 2015
Last updated: July 7, 2017
Last verified: July 2017
History of Changes
August 11, 2015
July 7, 2017
August 18, 2015
October 17, 2017   (Final data collection date for primary outcome measure)
Change from Baseline in Daily average Low Back Pain Intensity (LBPI) Score [ Time Frame: Week 16 ]
Change from Baseline to Week 16 in the daily average Low Back Pain Intensity (LBPI) score as measured by an 11 point Numeric Rating Scale for tanezumab vs placebo
Same as current
Complete list of historical versions of study NCT02528253 on ClinicalTrials.gov Archive Site
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Week 16 ]
    Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) for tanezumab vs placebo
  • Change from Baseline in Daily average Low Back Pain Intensity (LBPI) Score [ Time Frame: Week 16 ]
    Change from Baseline to Week 16 in the daily average LBPI score as measured by an 11 point Numeric Rating Scale for tanezumab vs tramadol PR.
  • Change from Baseline in Daily average Low Back Pain Intensity (LBPI) Score [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48, 56, and 64 ]
    Change from Baseline to Weeks 2, 4, 8, 12, 24, 32, 40, 48, 56, and 64 in average LBPI score
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Weeks 2, 4, 8, 16 (for tanezumab vs tramadol) 24, 32, 40, 48, 56, 64 and 80 ]
    Change from Baseline to Weeks 2, 4, 8, 16 (for tanezumab vs tramadol) 24, 32, 40, 48, 56, 64 and 80 in RMDQ total score
  • Patient's Global Assessment of Low Back Pain [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 ]
    Change from Baseline to Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 in Patient's Global Assessment of Low Back Pain
  • Cumulative distribution of percent change from Baseline in average Low Back Pain Intensity (LBPI) score [ Time Frame: Weeks 16, 24, and 56 ]
    Cumulative distribution of percent change from Baseline in average LBPI score to Weeks 16, 24, and 56 (endpoint for summary only)
  • Pain Intensity Response [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56, and 64 ]
    Response as defined by a >=30%, >=50%, >=70% and>=90% reduction from Baseline in daily average LBPI score derived from the subject diary at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56, and 64.
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Weeks 16, 24, and 56 ]
    Cumulative distribution of percent change from Baseline in RMDQ score to Weeks 16, 24, and 56
  • Change from Baseline in the Brief Pain Inventory short form (BPI-sf) [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 ]
    Change from Baseline to Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64 in the Brief Pain Inventory short form (BPI sf) scores for Worst Pain, Average Pain, Pain Interference Index (composite function score), Pain Interference with General Activity, Pain Interference with Walking Ability, Pain Interference with Sleep, and Pain Interference with Normal Work
  • Chronic Low Back Pain (CLBP) Responder Index [ Time Frame: Weeks 2, 4, 8 16, 24, 32, 40, 48 and 56 ]
    Chronic Low Back Pain Responder Index analysis [composite endpoint of average LBPI score, Patient's Global Assessment of Low Back Pain, and RMDQ total score at Weeks 2, 4, 8 16, 24, 32, 40, 48 and 56
  • Patients Global Assessment of Low Back Pain Treatment Response [ Time Frame: Weeks 2, 4, 8 16, 24, 32, 40, 48, and 64 ]
    Treatment Response: Improvement of >=2 points in Patient's Global Assessment of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, and 64
  • Euro Quality of Life Health State Profile (EQ 5D 5L) [ Time Frame: Weeks 8, 16, 24, 40, 56, and 64 ]
    Euro Quality of Life Health State Profile (EQ 5D 5L) dimensions and overall health utility score at Baseline, Weeks 8, 16, 24, 40, 56, and 64;
  • Work Productivity and Activity Impairment Questionnaire: Low Back Pain [ Time Frame: Weeks 16, 56, or 64 ]
    Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP) change from Baseline to Weeks 16, 56, or 64, in the percent work time missed due to chronic low back pain, percent impairment while working due to chronic low back pain, percent overall work impairment due to chronic low back pain, and percent activity impairment due to chronic low back pain
  • Discontinuation due to lack of efficacy [ Time Frame: Up to Week 56 ]
    Incidence of and time to discontinuation due to lack of efficacy
  • Usage of rescue medication [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and Week 64 ]
    Usage of rescue medication (incidence, and number of days of usage);
  • Usage of rescue medication [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
    Usage of rescue medication (amount taken) during Weeks 2, 4, 8, 12 and 16
  • Health Care Resource Utilization [ Time Frame: Baseline, Weeks 64 and 80 ]
    Data will be summarized for each timepoint
  • Roland Morris Disability Questionnaire (RMDQ) Response [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 ]
    Response as defined by a >=30%, >=50%, >=70% and>=90% reduction from Baseline Baseline in the RMDQ score at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 16 and 56 ]
    Data will be summarized for each timepoint.
  • Patient Reported Treatment Impact Assessment Modified [ Time Frame: Weeks 16 and 56 ]
    Data will be summarized for each timepoint.
Same as current
Not Provided
Not Provided
 
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Low Back Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
January 16, 2019
October 17, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Canada,   Denmark,   France,   Hungary,   Japan,   Korea, Republic of,   Spain,   Sweden,   United States
 
 
NCT02528253
A4091059
2012-005495-34 ( EudraCT Number )
CLBP SC STUDY ( Other Identifier: Alias Study Number )
A4091059 ( Other Identifier: Pfizer )
TANGO ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Eli Lilly and Company
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2017

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