Clinical trial NCT00584870: RN624 In Adult Patients With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12
timeFrame: Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12
measure: Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12
measure: Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less
timeFrame: Week 1, 2, 4, 6, 8, 12
measure: Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6
timeFrame: Week 6
measure: Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
timeFrame: Week 12
measure: Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
timeFrame: Weeks 1, 2, 4, 6, 8, 12
measure: Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
timeFrame: Randomization to Last Study Visit (up to 16 weeks)
measure: Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
timeFrame: Week 1 up to Week 12
measure: Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12
measure: Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12
measure: Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12
timeFrame: Week 1, 2, 4, 6, 8, 12
measure: Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication
timeFrame: Week 1, 2, 4, 6, 8, 12
measure: Number of Participants Who Discontinued the Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 12
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 12
measure: Number of Participants With Chronic Low Back Pain (CLBP) Response
timeFrame: Weeks 1, 2, 4, 6, 8, 12
measure: Number of Participants Who Used Rescue Medications
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Duration of Rescue Medication Use
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Amount of Rescue Medication Taken
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose of study treatment (up to Week 16)
measure: Number of Participants With Anti-Drug Antibody (ADA)
timeFrame: Baseline up to Week 12
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group LLC
state: Alabama
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Chandler
country: United States
facility: Radiant Research - Phoenix Southeast
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: DeFuniak Springs
country: United States
facility: Doctors Medical Center of Walton County
state: Florida
city: Destin
country: United States
facility: SJS Clinical Research, Inc.
state: Florida
city: Longwood
country: United States
facility: Adult Medicine Specialists
state: Florida
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Picayune
country: United States
facility: Spence Medical Research
state: Mississippi
city: Saint Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Lenoir
country: United States
facility: North State Clinical Research, PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Johnson City
country: United States
facility: Advanced Therapeutics, Inc.
state: Tennessee
city: Johnson City
country: United States
facility: Johnson City Internal Medicine
state: Tennessee
city: Bryan
country: United States
facility: DiscoveResearch, Incorporated
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Nassau Bay
country: United States
facility: Centex Research
state: Texas
city: Nassau Bay
country: United States
facility: Immediate Medical Care
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: Virginia Beach
country: United States
facility: Independence Family Medicine
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: