Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain
1 other identifier
interventional
922
1 country
98
Brief Summary
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
98 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
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 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
2.1 years
July 20, 2011
December 1, 2014
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Number of Participants With Adverse Events as a Measure of Safety
Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.
Up to 84 weeks
Daily "Average Pain Over the Last 24 Hours"
"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).
Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)
Secondary Outcomes (7)
"Pain Right Now" Score
Week 12
Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)
Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period
Brief Pain Inventory Short Form (BPI-SF)
Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period
Medical Outcomes Study 36-item Short Form (SF-36)
Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period
Patient Global Impression of Change (PGIC)
At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period
- +2 more secondary outcomes
Study Arms (1)
Hydrocodone bitartrate
EXPERIMENTALHydrocodone bitartrate (HYD) once daily (q24h) tablets
Interventions
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 nonmalignant and nonneuropathic pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to the screening visit;
- 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);
- Subjects who are willing and able to be compliant with the protocol, are capable of subjective evaluation (ie pain scores), are able to read and understand questionnaires, are willing and able to use an electronic diary, and are able to read, understand, and sign the written informed consent form in English.
You may not qualify if:
- Subjects taking opioid analgesic(s) equivalent to \> 120 mg/day of oxycodone during the 14 days prior to the screening visit;
- Subjects who previously participated in an investigational hydrocodone study within 90 days prior to the first dose of study medication ;
- Subjects who have used any investigational medication other than hydrocodone within 30 days prior to the first dose of study drug;
- 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 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 with history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
- 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 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;
- Subjects who are allergic to hydrocodone or who have a history of allergies to other opioids. This does not include subjects who have experienced common opioid side effects (eg, nausea, constipation);
- Subjects receiving monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs within 2 weeks of the screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (98)
Alliance Clinical Research
Birmingham, Alabama, 35213, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
ACRI -Phase1, LLC
Anaheim, California, 92801-2417, United States
United Clinical Research Center, Inc.
Anaheim, California, 92804, United States
Med Center
Carmichael, California, 95608, United States
Research Center of Fresno, Inc.
Fresno, California, 93726, United States
TriWest Research Associates
La Mesa, California, 91942, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Skyline Research, LLC
Long Beach, California, 90806, United States
Lotus Clinical Research, LLC
Pasadena, California, 91105, 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
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
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
MD Clinical
Hallandale, Florida, 33009, 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
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, 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
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
Leawood, Kansas, 66211, 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
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472-3930, United States
Medical Research Associates, Inc.
Traverse City, Michigan, 49684, 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
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Research Across America
New York, New York, 10022, 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
Pennsylvania Research Institute
Bensalem, Pennsylvania, 19020, 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
Pain Research of Charleston
Charleston, South Carolina, 29406, United States
Radiant Research, Inc.
Greer, South Carolina, 29651, United States
Health Concepts
Rapid City, South Dakota, 57702, 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
Lovelace Scientific Resources, Inc.
Austin, Texas, 78758, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Heights Doctor's Clinic
Houston, Texas, 77008, United States
JVC Family Medicine
Houston, Texas, 77040, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77098, United States
TEAM Research of Central Texas
Killeen, Texas, 76543, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, 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 (4)
Wen W, Taber L, Lynch SY, He E, Ripa S. 12-Month safety and effectiveness of once-daily hydrocodone tablets formulated with abuse-deterrent properties in patients with moderate to severe chronic pain. J Opioid Manag. 2015 Jul-Aug;11(4):339-56. doi: 10.5055/jom.2015.0283.
PMID: 26312961RESULTCampbell 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: 28072811DERIVEDKapil RP, Cipriano A, Wen W, Yu Lynch S, He E, Colucci SV, Harris SC. Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties. Clin Ther. 2016 Feb;38(2):302-14. doi: 10.1016/j.clinthera.2015.12.003. Epub 2015 Dec 31.
PMID: 26749219DERIVEDTaber L, Lynch SY, He E, Ripa SR. Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain. Postgrad Med. 2016 Jan;128(1):23-33. doi: 10.1080/00325481.2016.1134022. Epub 2016 Jan 12.
PMID: 26681111DERIVED
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2011
First Posted
July 22, 2011
Study Start
July 1, 2011
Primary Completion
August 1, 2013
Study Completion
October 1, 2013
Last Updated
March 10, 2020
Results First Posted
December 4, 2014
Record last verified: 2020-03