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

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ClinicalTrials.gov Identifier: NCT02528253
Recruitment Status : Active, not recruiting
First Posted : August 19, 2015
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Biological: Placebo to Week 16; tanezumab 5mg SC Biological: Placebo to Week 16, tanezumab 10 mg SC Biological: Tanezumab 5 mg SC Biological: Tanezumab 10 mg SC Biological: Tramadol PR oral Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo to Week 16; tanezumab 5 mg SC 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
Placebo Comparator: Placebo to Week 16, tanezumab 10 mg SC 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
Experimental: Tanezumab 5 mg SC Biological: Tanezumab 5 mg SC
Tanezumab 5 mg SC
Experimental: Tanezumab 10 mg SC Biological: Tanezumab 10 mg SC
Tanezumab 10 mg SC
Active Comparator: Tramadol PR oral Biological: Tramadol PR oral
Tramadol PR oral



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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;

  13. 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

  14. Discontinuation due to lack of efficacy [ Time Frame: Up to Week 56 ]
    Incidence of and time to discontinuation due to lack of efficacy

  15. 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);

  16. 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

  17. Health Care Resource Utilization [ Time Frame: Baseline, Weeks 64 and 80 ]
    Data will be summarized for each timepoint

  18. 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

  19. Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 16 and 56 ]
    Data will be summarized for each timepoint.

  20. Patient Reported Treatment Impact Assessment Modified [ Time Frame: Weeks 16 and 56 ]
    Data will be summarized for each timepoint.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528253


  Show 255 Study Locations
Sponsors and Collaborators
Pfizer
Eli Lilly and Company
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02528253     History of Changes
Other Study ID Numbers: A4091059
2012-005495-34 ( EudraCT Number )
CLBP SC STUDY ( Other Identifier: Alias Study Number )
A4091059 ( Other Identifier: Pfizer )
TANGO ( Other Identifier: Alias Study Number )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Chronic low back pain
Chronic pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents