At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, ACTIVE- AND PLACEBO-CONTROLLED, MULTI-CENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN
In Brief
A Phase 2 clinical trial evaluating Tanezumab 20 mg IV, Placebo for naproxen, and 4 other interventions for Low Back Pain. Completed, enrolled 1,359 participants across 135 sites.
Detailed 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.
Study Details
Timeline
Interventions
2 IV administrations of tanezumab 20 mg at an 8 week interval
Oral placebo for naproxen twice a day for 16 weeks
2 IV administrations of tanezumab 10 mg at an 8 week interval
Oral placebo for naproxen twice a day for 16 weeks
2 IV administrations of tanezumab 5 mg at an 8 week interval
Oral placebo for naproxen twice a day for 16 weeks
2 IV administrations of placebo for tanezumab at an 8 week interval
Oral naproxen 500 mg twice a day for 16 weeks
2 IV administrations of placebo for tanezumab at an 8 week interval
Oral placebo for naproxen twice a day for 16 weeks