Conditions: Low Back Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Naproxen intervention 2: Placebo intervention 3: PF-04383119 (RN624)
Intervention descriptions: intervention 1: Oral naproxen 500 mg twice daily for Weeks 1-12. intervention 2: Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12. intervention 3: Single IV infusion of 200 micrograms/kg RN624 on Day 1

Protocol document: