Overview

RN624 In Adult Patients With Chronic Low Back Pain

Status:
Completed
Trial end date:
2008-09-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Naproxen
Tanezumab
Criteria
Inclusion Criteria:

- Male or female of any race, >18 years of age and have BMI ≤39 kg/m2

- Present with duration of chronic low back pain of ≥3 months requiring regular use of
analgesic medication (>4 days per week for the past month)

- Primary location of low back pain is between the 12th thoracic vertebra and the lower
gluteal folds, with or without radiation into the posterior thigh, classified as
Category 1 or 2 according to the classification of the Quebec Task Force in Spinal
Disorders

- Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment
at Screening, and completes at least 4 daily pain diaries during the 5 days prior to
Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

Exclusion Criteria:

- Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent
major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)

- History of lumbosacral radiculopathy, spinal stenosis associated with neurological
impairment, or neurogenic claudication

- Osteoporotic compression fracture within the last 6 months

- Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e.,
ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel
disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia;
Tumors or infections of the spinal cord

- Patients receiving acetaminophen only to manage their chronic low back pain

- Any uncontrolled or untreated chronic disease