RN624 In Adult Patients With Chronic Low Back Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT00584870

Run by

Pfizer

People needed

220

Starts

2007-07-05

Expected to finish

2008-09-02

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group LLC — Anniston, Alabama, United States
• Radiant Research — Birmingham, Alabama, United States
• Radiant Research - Phoenix Southeast — Chandler, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• University of California San Diego — San Diego, California, United States
• Doctors Medical Center of Walton County — DeFuniak Springs, Florida, United States
• SJS Clinical Research, Inc. — Destin, Florida, United States
• Adult Medicine Specialists — Longwood, Florida, United States
• Genesis Research International — Longwood, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Cotton-O'Neil Clinical Research — Topeka, Kansas, United States
• Cotton-O'Neil Clinic — Topeka, Kansas, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Northeast Medical Research Associates, Inc — North Dartmouth, Massachusetts, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Spence Medical Research — Picayune, Mississippi, United States
• Radiant Research, Inc. — St Louis, Missouri, United States
• Quality Clinical Research, Inc. — Omaha, Nebraska, United States
• The Medical Research Network, LLC — New York, New York, United States
• North State Clinical Research, PLLC — Lenoir, North Carolina, United States
• Wake Internal Medicine Consultants, Inc. — Raleigh, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Summit Research Network (Oregon), Inc. — Portland, Oregon, United States
• Allegheny Pain Management — Altoona, Pennsylvania, United States

Full record on ClinicalTrials.gov

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