A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately ...

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Reference: EUCTR2009-009857-17

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain

Woman and Man

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Extract

The primary objectives of this study are to evaluate the analgesic effect size over 12 weeks of several doses and dosage regimens of JNJ-42160443 compared with placebo in subjects with moderate to severe, chronic, low back pain (LBP) that is not adequately controlled by standard pain therapy, and to evaluate the safety and tolerability of multiple SC doses of JNJ-42160443 in this population.


Inclusion criteria

  • Moderate to severe, chronic, low back pain (LBP) that is not adequately controlled by standard pain therapy