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RN624 In Adult Patients With Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584870
First Posted: January 2, 2008
Last Update Posted: October 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Low Back Pain Drug: Naproxen Drug: Placebo Drug: PF-04383119 (RN624) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in the mBPI-sf score for Pain. [ Time Frame: 12 weeks ]
  • 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. [ Time Frame: 12 weeks ]
  • 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). [ Time Frame: 12 weeks ]
  • 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. [ Time Frame: 12 weeks ]
  • 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. [ Time Frame: 12 weeks ]
  • Percent change from Baseline in the LBPI NRS score through Week 6. [ Time Frame: 6 weeks ]
  • Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in Roland-Morris Disability Questionnaire total score. [ Time Frame: 12 weeks ]
  • Patient's Global Evaluation of Study Medication (treatment response) score at Weeks 1, 2, 4, 6, 8 and 12. [ Time Frame: 12 weeks ]
  • 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). [ Time Frame: 12 weeks ]
  • Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in Patient's Global Assessment of Low Back Pain (disease activity) score. [ Time Frame: 12 weeks ]
  • Total duration of response as defined by days with a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score. [ Time Frame: 12 weeks ]
  • Change from Baseline to Weeks 1, 2, 4, 8 and 12 in the LBPI NRS score derived from the patient daily diary. [ Time Frame: 12 weeks ]
  • 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. [ Time Frame: 12 weeks ]

Enrollment: 225
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naproxen Drug: Naproxen
Oral naproxen 500 mg twice daily for Weeks 1-12.
Placebo Comparator: Placebo Drug: Placebo
Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
Experimental: RN624 Drug: PF-04383119 (RN624)
Single IV infusion of 200 micrograms/kg RN624 on Day 1

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584870


  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Pfizer Investigational Site
Chandler, Arizona, United States, 85225
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
San Diego, California, United States, 92121
United States, Florida
Pfizer Investigational Site
DeFuniak Springs, Florida, United States, 32435
Pfizer Investigational Site
Destin, Florida, United States, 32541
Pfizer Investigational Site
Longwood, Florida, United States, 32779
Pfizer Investigational Site
Naples, Florida, United States, 34102
United States, Kansas
Pfizer Investigational Site
Topeka, Kansas, United States, 66606
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, Massachusetts
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Mississippi
Pfizer Investigational Site
Picayune, Mississippi, United States, 39466
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10024
United States, North Carolina
Pfizer Investigational Site
Lenoir, North Carolina, United States, 28645
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16602
United States, Rhode Island
Pfizer Investigational Site
Cranston, Rhode Island, United States, 02920
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
Pfizer Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Pfizer Investigational Site
Bryan, Texas, United States, 77802
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Nassau Bay, Texas, United States, 77058
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23455
United States, Washington
Pfizer Investigational Site
Bellevue, Washington, United States, 98004
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00584870     History of Changes
Other Study ID Numbers: A4091004
First Submitted: December 21, 2007
First Posted: January 2, 2008
Last Update Posted: October 5, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action