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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Naproxen
  • Oral naproxen 500 mg twice daily for Weeks 1-12.
• Drug: Placebo
  • Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
• Drug: PF-04383119 (RN624)
  • Single IV infusion of 200 micrograms/kg RN624 on Day 1

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Naproxen
• Placebo Comparator: Placebo
• Experimental: RN624

Primary 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
    Safety Issue?: No

Secondary Measures

• Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in the mBPI-sf score for Pain.
  • Time Frame: 12 weeks
    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
    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
    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
    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
    Safety Issue?: No
• Percent change from Baseline in the LBPI NRS score through Week 6.
  • Time Frame: 6 weeks
    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
    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
    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
    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
    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
    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
    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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

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