Official Title: “Phase II Randomized, Double-Blind, Placebo And Active Controlled, Multicenter, Parallel Group Proof Of Concept Study Of The Analgesic Effects Of RN624 In Adult Patients With Chronic Low Back Pain”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary:

• change from Baseline to Week 6 in the daily Low Back Pain Intensity (LBPI) as measured by an 11-point Numeric Rating Scale (NRS) derived from the patient daily diary 6 weeks No

Secondary:

• Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in Patient's Global Assessment of Low Back Pain (disease activity) score. 12 weeks No
• Total duration of response as defined by days with a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score. 12 weeks No
• Change from Baseline to Weeks 1, 2, 4, 8 and 12 in the LBPI NRS score derived from the patient daily diary. 12 weeks No
• Change from Baseline in average pain over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 in the LBPI NRS score derived from the patient daily diary. 12 weeks No
• Response as defined by a ≥30% and a ≥50% reduction from Baseline in the LBPI NRS score derived from the patient daily diary at Weeks 1, 2, 4, 6, 8, and 12. 12 weeks No
• Time to a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score (sustained for a minimum of 4 consecutive days). 12 weeks No
• Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12 in the Modified Brief Pain Inventory-short form (mBPI-sf) scores for Worst Pain and Average Pain obtained at study visits. 12 weeks No
• Response as defined by a score of ≤2 in the mean daily average LBPI NRS score during Weeks 1, 2, 4, 6, 8, and 12 as derived from the daily patient e-diary. 12 weeks No
• Percent change from Baseline in the LBPI NRS score through Week 6. 6 weeks No
• Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in Roland-Morris Disability Questionnaire total score. 12 weeks No
• Patient's Global Evaluation of Study Medication (treatment response) score at Weeks 1, 2, 4, 6, 8 and 12. 12 weeks No
• Response as defined by a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score (sustained for a minimum of 4 consecutive days). 12 weeks No
• Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in the mBPI-sf score for Pain. 12 weeks No

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

Lead Sponsor: Pfizer

Pfizer Investigational Site

Birmingham Alabama 35209 United States

Pfizer Investigational Site

Anniston Alabama 36207 United States

Pfizer Investigational Site

Chandler Arizona 85225 United States

Pfizer Investigational Site

Scottsdale Arizona 85251 United States

Pfizer Investigational Site

Anaheim California 92801 United States

Pfizer Investigational Site

San Diego California 92121 United States

Pfizer Investigational Site

Naples Florida 34102 United States

Pfizer Investigational Site

DeFuniak Springs Florida 32435 United States

Pfizer Investigational Site

Destin Florida 32541 United States

Pfizer Investigational Site

Longwood Florida 32779 United States

Pfizer Investigational Site

Wichita Kansas 67207 United States

Pfizer Investigational Site

Topeka Kansas 66606 United States

Pfizer Investigational Site

North Dartmouth Massachusetts 02747 United States

Pfizer Investigational Site

Worcester Massachusetts 01610 United States

Pfizer Investigational Site

Picayune Mississippi 39466 United States

Pfizer Investigational Site

St. Louis Missouri 63110 United States

Pfizer Investigational Site

Omaha Nebraska 68114 United States

Pfizer Investigational Site

New York New York 10024 United States

Pfizer Investigational Site

Raleigh North Carolina 27612 United States

Pfizer Investigational Site

Lenoir North Carolina 28645 United States

Pfizer Investigational Site

Portland Oregon 97210 United States

Pfizer Investigational Site

Altoona Pennsylvania 16602 United States

Pfizer Investigational Site

Warwick Rhode Island 02886 United States

Pfizer Investigational Site

Cranston Rhode Island 02920 United States

Pfizer Investigational Site

Cumberland Rhode Island 02864 United States

Pfizer Investigational Site

Greer South Carolina 29651 United States

Pfizer Investigational Site

Johnson City Tennessee 37601 United States

Pfizer Investigational Site

San Antonio Texas 78229 United States

Pfizer Investigational Site

Houston Texas 77030 United States

Pfizer Investigational Site

Bryan Texas 77802 United States

Pfizer Investigational Site

Nassau Bay Texas 77058 United States

Pfizer Investigational Site

Virginia Beach Virginia 23455 United States

Pfizer Investigational Site

Bellevue Washington 98004 United States

Pfizer Investigational Site

Seattle Washington 98104 United States

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00584870

Study ID Number: A4091004

ClinicalTrials.gov Identifier: NCT00584870

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.