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RN624 In Adult Patients With Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584870
First received: December 21, 2007
Last updated: October 1, 2009
Last verified: October 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from Baseline in the LBPI NRS score through Week 6. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in Roland-Morris Disability Questionnaire total score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication (treatment response) score at Weeks 1, 2, 4, 6, 8 and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: 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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00584870     History of Changes
Other Study ID Numbers: A4091004
Study First Received: December 21, 2007
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014