drugset / Trial / NCT00876187
A Study of Tanezumab in Adults With Chronic Low Back Pain
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.
Timeline
- Start
- 2009-06-15
- Primary completion
- 2010-06-16
- Completion
- 2011-02-01
Publications
- Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
- Kivitz AJ, Gimbel JS, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain. 2013 Jul;154(7):1009-21. doi: 10.1016/j.pain.2013.03.006. Epub 2013 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naproxen | Small molecule | 500 mg | Oral |
| Subject | Tanezumab | Monoclonal antibody | 5 mg | Intravenous |
| Subject | Tanezumab | Monoclonal antibody | 10 mg | Intravenous |
| Subject | Tanezumab | Monoclonal antibody | 20 mg | Intravenous |
Indications
No indication recorded.