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Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

CompletedPhase 3NCT02725411
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).

Study details

Official title
A Phase 3 Randomized, Double-Blind, Active-Controlled, Multicenter Study Of The Long-Term Safety And Efficacy Of Subcutaneous Administration Of Tanezumab In Japanese Adult Subjects With Chronic Low Back Pain
Conditions
Interventions
Sponsor
Pfizer
Start date
2016-05-26
Primary completion
2019-06-11
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Japan
Total sites listed
55

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Duration of chronic low back pain for ≥3 months, and treatment with agents for low back pain for ≥3 months. * Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders. * Subjects must be experiencing some benefits from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment as described in the protocol, be tolerating their NSAID regimen, be taking this medication regularly during the 30 day period prior to the Screening visit and must have had some improvement in low back pain, but still require additional pain relief at Screening. * Subjects must maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period. * Low Back Pain Intensity (LBPI) score of ≥5 at Screening. * Subjects must be willing to discontinue all pain medications for chronic low back pain except rescue medication and investigational product and not use prohibited pain medications throughout the duration of the study. * Female subjects of childbearing potential and at risk for pregnancy must agree to comply with protocol specified contraceptive requirements. Exclusion Criteria: * Subjects exceeding protocol defined BMI limits. * Diagnosis of osteoarthritis of the knee or hip as defined by the ACR combined clinical and radiographic 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. * Subjects who have Kellgren Lawrence Grade \< or =2 radiographic evidence of knee osteoarthritis but who do not meet ACR criteria and do not have pain associated with their knee osteoarthritis will be allowed. * Subjects with symptoms and radiologic findings consistent with osteoarthritis in the shoulder. * History of lumbosacral radiculopathy within the past 2 years, history of spinal stenosis associated with neurological impairment, or history of neurogenic claudication. * Back pain due to recent major trauma within 6 months prior to Screening. * Surgical intervention during the past 6 months for the treatment of low back pain. * Planned surgical procedure during the duration of the study. * History or radiographic evidence of other diseases that could confound efficacy …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02725411