A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain

Phase 2 Terminated 389 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.

Timeline

Start: 2009-09
Primary completion: 2011-05
Completion: 2011-05

Publications

Sanga P, Polverejan E, Wang S, Kelly KM, Thipphawong J. Efficacy, Safety, and Tolerability of Fulranumab as an Adjunctive Therapy in Patients With Inadequately Controlled, Moderate-to-Severe Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Dose-loading Phase II Study. Clin Ther. 2016 Jun;38(6):1435-1450. doi: 10.1016/j.clinthera.2016.03.030. Epub 2016 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fulranumab	Monoclonal antibody	1 mg	Subcutaneous
Subject	Fulranumab	Monoclonal antibody	3 mg	Subcutaneous
Subject	Fulranumab	Monoclonal antibody	10 mg	Subcutaneous

Indications

No indication recorded.