Conditions: Low Back Pain
Keywords: randomized controlled trial monoclonal antibody nerve growth factor naproxen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1359
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Tanezumab 20 mg IV intervention 2: Placebo for naproxen intervention 3: Tanezumab 10 mg IV intervention 4: Placebo for naproxen intervention 5: Tanezumab 5 mg IV intervention 6: Placebo for naproxen intervention 7: Placebo for tanezumab intervention 8: Naproxen intervention 9: Placebo for tanezumab intervention 10: Placebo for naproxen
Intervention descriptions: intervention 1: 2 IV administrations of tanezumab 20 mg at an 8 week interval intervention 2: Oral placebo for naproxen twice a day for 16 weeks intervention 3: 2 IV administrations of tanezumab 10 mg at an 8 week interval intervention 4: Oral placebo for naproxen twice a day for 16 weeks intervention 5: 2 IV administrations of tanezumab 5 mg at an 8 week interval intervention 6: Oral placebo for naproxen twice a day for 16 weeks intervention 7: 2 IV administrations of placebo for tanezumab at an 8 week interval intervention 8: Oral naproxen 500 mg twice a day for 16 weeks intervention 9: 2 IV administrations of placebo for tanezumab at an 8 week interval intervention 10: Oral placebo for naproxen twice a day for 16 weeks

Protocol document: