Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Drug: Placebo to match hydrocodone bitartrate q24h tablets
- Registration Number
- NCT01452529
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 905
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydrocodone bitartrate Hydrocodone bitartrate q24h film-coated tablets Hydrocodone bitartrate (HYD) once daily (q24h) tablets Placebo Placebo to match hydrocodone bitartrate q24h tablets Placebo to match hydrocodone bitartrate once daily tablets
- Primary Outcome Measures
Name Time Method Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score Week 12 Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
- Secondary Outcome Measures
Name Time Method Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale Weeks 4, 8, and 12 The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - "all of the time" to 5 - "none of the time". Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern.
Patient Global Impression of Change (PGIC) Week 12 The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "very much improved" and "much improved" was summarized by treatment group.
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline Baseline to Week 12 A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline Baseline to Week 12 A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.
Trial Locations
- Locations (98)
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
CRI Worldwide LLC
🇺🇸Willingboro, New Jersey, United States
Hartwell Research Group
🇺🇸Anderson, South Carolina, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Daystar Clinical Research, Inc.
🇺🇸Akron, Ohio, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Redpoint Research
🇺🇸Tucson, Arizona, United States
Georgia Institute for Clinical Research, LLC
🇺🇸Marietta, Georgia, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Fidelity Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Sarasota Research, LLC
🇺🇸Sarasota, Florida, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
MedVadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Northwest Indiana Center for Clinical Research
🇺🇸Valparaiso, Indiana, United States
PMG Research of Wilmington LLC
🇺🇸Wilmington, North Carolina, United States
United Clinical Research Center, Inc.
🇺🇸Anaheim, California, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Peninsula Research Inc.
🇺🇸Ormond Beach, Florida, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Florida Health Center
🇺🇸Fort Lauderdale, Florida, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Taylor Research, LLC
🇺🇸Marietta, Georgia, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Southeast Regional Research Group
🇺🇸Columbus, Georgia, United States
Medex Healthcare Research, Inc.
🇺🇸Saint Louis, Missouri, United States
Mercy Health Research
🇺🇸Saint Louis, Missouri, United States
Atlanta Knee and Shoulder Clinic, PC
🇺🇸Stockbridge, Georgia, United States
QUEST Research Institute
🇺🇸Bingham Farms, Michigan, United States
Research Center of Fresno, Inc.
🇺🇸Fresno, California, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
Advance Clinical Research
🇺🇸Saint Louis, Missouri, United States
TriWest Research Associates
🇺🇸La Mesa, California, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
IVA Research
🇺🇸Cincinnati, Ohio, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Radiant Research, Inc.
🇺🇸Greer, South Carolina, United States
Illinois Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Heights Doctor's Clinic
🇺🇸Houston, Texas, United States
Neuroscience Consultants LLC
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Research Facility
🇺🇸Las Vegas, Nevada, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Journey Research, Inc
🇺🇸Oldsmar, Florida, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸Tucson, Arizona, United States
ACRI-Phase 1, LLC
🇺🇸Anaheim, California, United States
Skyline Research, LLC
🇺🇸Long Beach, California, United States
Center for Clinical Research, Inc.
🇺🇸Richmond, California, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Advent Clinical Research Centers, Inc.
🇺🇸Pinellas Park, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Better Health Clinical Research, Inc.
🇺🇸Newnan, Georgia, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
ICRI
🇺🇸Overland Park, Kansas, United States
Rehabilitation Associates of Indiana
🇺🇸Indianapolis, Indiana, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
IRC Clinics, Inc.
🇺🇸Towson, Maryland, United States
Medical Research Associates, Inc.
🇺🇸Traverse City, Michigan, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Bone Joint and Spine Surgeons, Inc.
🇺🇸Toledo, Ohio, United States
Allegheny Pain Management, P.C.
🇺🇸Altoona, Pennsylvania, United States
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Tipton Medical & Diagnostic Center
🇺🇸Tipton, Pennsylvania, United States
Founders Research Corporation
🇺🇸Philadelphia, Pennsylvania, United States
Comprehensive Pain Specialists, LLC
🇺🇸Hendersonville, Tennessee, United States
HCCA Clinical Research Solutions
🇺🇸Smyrna, Tennessee, United States
Heartland Medical, PC
🇺🇸New Tazewell, Tennessee, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Aspen Clinical Research
🇺🇸Orem, Utah, United States
Washington Center for Pain Management
🇺🇸Edmonds, Washington, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
HypotheTest, LLC
🇺🇸Roanoke, Virginia, United States
Northern California Research
🇺🇸Sacramento, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Clinical Trials of America, Inc.
🇺🇸Winston-Salem, North Carolina, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States