RN624 In Adult Patients With Chronic Low Back Pain

Pfizer

Status and phase: Completed; Phase 2

Conditions: Low Back Pain

Treatments: Drug: PF-04383119 (RN624); Drug: Naproxen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00584870

A4091004

CLBP POC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 3 patient groups, including a placebo group

Naproxen

Active Comparator group

Treatment:

Drug: Naproxen

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RN624

Experimental group

Treatment:

Drug: PF-04383119 (RN624)