RN624 In Adult Patients With Chronic Low Back Pain - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00584870

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 II

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

MedlinePlus related topics: Back Pain

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

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
Naproxen: Active Comparator	Drug: Naproxen Oral naproxen 500 mg twice daily for Weeks 1-12.
Placebo: Placebo Comparator	Drug: Placebo Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
RN624: Experimental	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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A4091004
Study First Received:	December 21, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00584870 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Naproxen
Cyclooxygenase Inhibitors
Low Back Pain
Pain
Back Pain
Signs and Symptoms

Analgesics, Non-Narcotic
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Low Back Pain
Enzyme Inhibitors
Pain
Gout Suppressants
Back Pain

Pharmacologic Actions
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009