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

Phase 3 Completed 277 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start: 2016-05-26
Primary completion: 2019-06-11
Completion: 2019-06-11

Publications

Konno SI, Nikaido T, Markman JD, Ohta M, Machida T, Isogawa N, Yoshimatsu H, Viktrup L, Brown MT, West CR, Verburg KM. Tanezumab for chronic low back pain: a long-term, randomized, celecoxib-controlled Japanese Phase III safety study. Pain Manag. 2022 Apr;12(3):323-335. doi: 10.2217/pmt-2021-0040. Epub 2021 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Celecoxib	Other / unclassified	100 mg	Oral
Subject	Tanezumab	Monoclonal antibody	5 mg	Subcutaneous
Subject	Tanezumab	Monoclonal antibody	10 mg	Subcutaneous

Indications

No indication recorded.