Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2007-07-05
2008-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naproxen
Naproxen
Oral naproxen 500 mg twice daily for Weeks 1-12.
Placebo
Placebo
Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
RN624
PF-04383119 (RN624)
Single IV infusion of 200 micrograms/kg RN624 on Day 1
Interventions
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Naproxen
Oral naproxen 500 mg twice daily for Weeks 1-12.
Placebo
Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
PF-04383119 (RN624)
Single IV infusion of 200 micrograms/kg RN624 on Day 1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Radiant Research
Scottsdale, Arizona, United States
Pinnacle Research Group LLC
Anniston, Alabama, United States
Radiant Research
Birmingham, Alabama, United States
Radiant Research - Phoenix Southeast
Chandler, 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
New England Center for Clinical Research
Cranston, Rhode Island, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Radiant Research
Greer, South Carolina, United States
Advanced Therapeutics, Inc.
Johnson City, Tennessee, United States
Johnson City Internal Medicine
Johnson City, Tennessee, United States
DiscoveResearch, Incorporated
Bryan, Texas, United States
Advances In Health, Inc.
Houston, Texas, United States
Centex Research
Nassau Bay, Texas, United States
Immediate Medical Care
Nassau Bay, Texas, United States
Radiant Research San Antonio
San Antonio, Texas, United States
Independence Family Medicine
Virginia Beach, Virginia, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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CLBP POC
Identifier Type: OTHER
Identifier Source: secondary_id
A4091004
Identifier Type: -
Identifier Source: org_study_id
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