Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain
1 other identifier
interventional
905
1 country
102
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2011
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
December 4, 2014
CompletedMarch 10, 2020
March 1, 2020
1.9 years
October 12, 2011
December 1, 2014
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score
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).
Week 12
Secondary Outcomes (4)
Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale
Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC)
Week 12
Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
Baseline to Week 12
Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
Baseline to Week 12
Study Arms (2)
Hydrocodone bitartrate
EXPERIMENTALHydrocodone bitartrate (HYD) once daily (q24h) tablets
Placebo
PLACEBO COMPARATORPlacebo to match hydrocodone bitartrate once daily tablets
Interventions
Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily
Eligibility Criteria
You may qualify if:
- Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;
- Subjects whose low back pain is not adequately treated prior to the screening visit with their stable incoming analgesic regimen;
- Subjects deemed by the investigator/medically qualified designee (must be MD or DO) to be appropriate candidates for the protocol specified, around the clock HYD therapeutic regimen;
- Female subjects who are premenopausal or postmenopausal less than 1 year and who have not had surgical sterilization (ie, tubal ligation, partial or complete hysterectomy) must have a negative serum pregnancy test, be nonlactating, and willing to use adequate and reliable contraception throughout the study (eg, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception).
You may not qualify if:
- Subjects taking \> 100 mg/day oxycodone or equivalent during last 14 days prior to screening visit;
- Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic pain, excluding herbal and nutraceutical medications;
- Subjects who cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, botulinum toxin injections for control of chronic low back pain, steroid injections in the lower back or inhalation analgesia). The subject must not have had a nerve/plexus block within 4 weeks of the screening visit, neuroablation within 6 months of the screening visit, a botulinum toxin injection in the low back region within 3 months of the screening visit, steroid injections in the lower back within 6 weeks of the screening visit, or intravenous or intramuscular steroid injections within 4 weeks of the screening visit;
- Subjects who have used any investigational medication within 30 days prior to the first dose of study medication;
- Subjects with any history of seizures (subjects with history of pediatric febrile seizures may participate in the study) or increase in intracranial pressure;
- Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on a stable medication for ≥ 1 month prior to the screening visit to participate in the study);
- Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time;
- Subjects with clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling pacemaker;
- Subjects with unstable respiratory disease that, in the opinion of the investigator, precludes entry into this study;
- Subjects with evidence of impaired liver function upon entry into the study (laboratory test values ≥ 3 times the upper limit of the laboratory reference (normal) range (ULN) for aspartate transaminase \[AST/SGOT\] or alanine transaminase \[ALT/SGPT\], or values \> 2 times the ULN for alkaline phosphatase), or total bilirubin level \> 1.5 times the ULN or, in the opinion of the investigator/medically qualified designee (must be MD or DO), liver function impairment to the extent that the subject should not participate in this study;
- Subjects with evidence of impaired kidney function upon entry into the study (ie, serum creatinine ≥ 2.5 mg/dL);
- Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that, in the opinion of the investigator, is inadequately treated and precludes entry into the study;
- Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or scheduled for surgery of the lower back or any other major surgery during the study conduct period;
- Subjects with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
- Subjects with any condition in which opioids are contraindicated, eg, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (102)
Alliance Clinical Research
Birmingham, Alabama, 35213, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Redpoint Research
Tucson, Arizona, 85712, United States
ACRI-Phase 1, LLC
Anaheim, California, 92801-2417, United States
Orange County Research Institute
Anaheim, California, 92801, United States
United Clinical Research Center, Inc.
Anaheim, California, 92804, United States
Research Center of Fresno, Inc.
Fresno, California, 93726, United States
TriWest Research Associates
La Mesa, California, 91942, United States
Torrance Clinical Research Institute Inc.
Lomita, California, 90717, United States
Skyline Research, LLC
Long Beach, California, 90806, United States
Center for Clinical Research, Inc.
Richmond, California, 94806, United States
Northern California Research
Sacramento, California, 95821, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Meridien Research
Bradenton, Florida, 34208, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Florida Health Center
Fort Lauderdale, Florida, 33312, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Fidelity Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Neuroscience Consultants LLC
Miami, Florida, 33176, United States
International Research Associates, LLC
Miami, Florida, 33183, United States
Journey Research, Inc
Oldsmar, Florida, 34677, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Peninsula Research Inc.
Ormond Beach, Florida, 32174, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, 33781, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Sarasota Research, LLC
Sarasota, Florida, 34243, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Southeast Regional Research Group
Columbus, Georgia, 31904, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Taylor Research, LLC
Marietta, Georgia, 30060, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265, United States
Atlanta Knee and Shoulder Clinic, PC
Stockbridge, Georgia, 30281, United States
Illinois Center for Clinical Research
Chicago, Illinois, 60622, United States
Rehabilitation Associates of Indiana
Indianapolis, Indiana, 46250, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
ICRI
Overland Park, Kansas, 66210, United States
Community Research
Crestview Hills, Kentucky, 41017, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
IRC Clinics, Inc.
Towson, Maryland, 21204, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472-3930, United States
QUEST Research Institute
Bingham Farms, Michigan, 48025, United States
Medical Research Associates, Inc.
Traverse City, Michigan, 49684, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Advance Clinical Research
St Louis, Missouri, 63128, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Research Facility
Las Vegas, Nevada, 89144, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
CRI Worldwide LLC
Willingboro, New Jersey, 08046, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Drug Trials America
Hartsdale, New York, 10530, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
PMG Research of Wilmington LLC
Wilmington, North Carolina, 28401, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, 27103, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Daystar Clinical Research, Inc.
Akron, Ohio, 44313, United States
IVA Research
Cincinnati, Ohio, 45245, United States
Community Research
Cincinnati, Ohio, 45255, United States
Bone Joint and Spine Surgeons, Inc.
Toledo, Ohio, 43623, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Allegheny Pain Management, P.C.
Altoona, Pennsylvania, 16602, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Founders Research Corporation
Philadelphia, Pennsylvania, 19152, United States
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, 16684, United States
Hartwell Research Group
Anderson, South Carolina, 29621, United States
Radiant Research, Inc.
Greer, South Carolina, 29651, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Comprehensive Pain Specialists, LLC
Hendersonville, Tennessee, 37075, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Heartland Medical, PC
New Tazewell, Tennessee, 37825, United States
HCCA Clinical Research Solutions
Smyrna, Tennessee, 37167, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Heights Doctor's Clinic
Houston, Texas, 77008, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
HypotheTest, LLC
Roanoke, Virginia, 24018, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Washington Center for Pain Management
Edmonds, Washington, 98026, United States
Related Publications (2)
Wen W, Sitar S, Lynch SY, He E, Ripa SR. A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain. Expert Opin Pharmacother. 2015;16(11):1593-606. doi: 10.1517/14656566.2015.1060221. Epub 2015 Jun 26.
PMID: 26111544RESULTCampbell K, Kutz JW Jr, Shoup A, Wen W, Lynch SY, He E, Ripa SR. Evaluation of the Ototoxicity Potential of Once-Daily, Single-Entity Hydrocodone in Patients with Chronic Pain: Results of Two Phase-3 Clinical Studies. Pain Physician. 2017 Jan-Feb;20(1):E183-E193.
PMID: 28072811DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Purdue Pharma L.P.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 17, 2011
Study Start
October 1, 2011
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
March 10, 2020
Results First Posted
December 4, 2014
Record last verified: 2020-03