RN624 In Adult Patients With Chronic Low Back Pain
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584870
First received: December 21, 2007
Last updated: October 1, 2009
Last verified: October 2009
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584870
Show 34 Study Locations
Show 34 Study LocationsSponsors 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 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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013