Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

NCT ID: NCT01452529

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 905 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-10-31

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

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hydrocodone bitartrate

Hydrocodone bitartrate (HYD) once daily (q24h) tablets

Group Type: EXPERIMENTAL

Hydrocodone bitartrate q24h film-coated tablets

Intervention Type: DRUG

Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

Placebo

Placebo to match hydrocodone bitartrate once daily tablets

Group Type: PLACEBO_COMPARATOR

Placebo to match hydrocodone bitartrate q24h tablets

Intervention Type: DRUG

Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Interventions

Hydrocodone bitartrate q24h film-coated tablets

Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

Intervention Type: DRUG

Placebo to match hydrocodone bitartrate q24h tablets

Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily

Intervention Type: DRUG

Other Intervention Names

Hysingla ER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alliance Clinical Research

Birmingham, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Redpoint Research

Phoenix, Arizona, United States

Genova Clinical Research

Tucson, Arizona, United States

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States

Redpoint Research

Tucson, Arizona, United States

ACRI-Phase 1, LLC

Anaheim, California, United States

Orange County Research Institute

Anaheim, California, United States

United Clinical Research Center, Inc.

Anaheim, California, United States

Research Center of Fresno, Inc.

Fresno, California, United States

TriWest Research Associates

La Mesa, California, United States

Torrance Clinical Research Institute Inc.

Lomita, California, United States

Skyline Research, LLC

Long Beach, California, United States

Center for Clinical Research, Inc.

Richmond, California, United States

Northern California Research

Sacramento, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Orthopedic Research Institute

Boynton Beach, Florida, United States

Meridien Research

Bradenton, Florida, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Florida Health Center

Fort Lauderdale, Florida, United States

Clinical Physiology Associates

Fort Myers, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Fidelity Clinical Research, Inc.

Lauderhill, Florida, United States

Neuroscience Consultants LLC

Miami, Florida, United States

International Research Associates, LLC

Miami, Florida, United States

Journey Research, Inc

Oldsmar, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

Peninsula Research Inc.

Ormond Beach, Florida, United States

Advent Clinical Research Centers, Inc.

Pinellas Park, Florida, United States

Gold Coast Research, LLC

Plantation, Florida, United States

Sarasota Research, LLC

Sarasota, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Southeast Regional Research Group

Columbus, Georgia, United States

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, United States

Taylor Research, LLC

Marietta, Georgia, United States

Better Health Clinical Research, Inc.

Newnan, Georgia, United States

Atlanta Knee and Shoulder Clinic, PC

Stockbridge, Georgia, United States

Illinois Center for Clinical Research

Chicago, Illinois, United States

Rehabilitation Associates of Indiana

Indianapolis, Indiana, United States

Northwest Indiana Center for Clinical Research

Valparaiso, Indiana, United States

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, United States

ICRI

Overland Park, Kansas, United States

Community Research

Crestview Hills, Kentucky, United States

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, United States

Louisiana Research Associates, Inc.

New Orleans, Louisiana, United States

IRC Clinics, Inc.

Towson, Maryland, United States

Beacon Clinical Research, LLC

Brockton, Massachusetts, United States

MedVadis Research Corporation

Watertown, Massachusetts, United States

QUEST Research Institute

Bingham Farms, Michigan, United States

Medical Research Associates, Inc.

Traverse City, Michigan, United States

Healthcare Research Network

Hazelwood, Missouri, United States

Medex Healthcare Research, Inc.

St Louis, Missouri, United States

Advance Clinical Research

St Louis, Missouri, United States

Mercy Health Research

St Louis, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Quality Clinical Research

Omaha, Nebraska, United States

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Research Facility

Las Vegas, Nevada, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

CRI Worldwide LLC

Willingboro, New Jersey, United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

Lovelace Scientific Resources

Albuquerque, New Mexico, United States

Drug Trials America

Hartsdale, New York, United States

The Medical Research Network, LLC

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Upstate Clinical Research Associates

Williamsville, New York, United States

PMG Research of Charlotte, LLC

Charlotte, North Carolina, United States

PMG Research of Wilmington LLC

Wilmington, North Carolina, United States

Clinical Trials of America, Inc.

Winston-Salem, North Carolina, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Daystar Clinical Research, Inc.

Akron, Ohio, United States

IVA Research

Cincinnati, Ohio, United States

Community Research

Cincinnati, Ohio, United States

Bone Joint and Spine Surgeons, Inc.

Toledo, Ohio, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Allegheny Pain Management, P.C.

Altoona, Pennsylvania, United States

CRI Worldwide, LLC

Philadelphia, Pennsylvania, United States

Founders Research Corporation

Philadelphia, Pennsylvania, United States

Tipton Medical & Diagnostic Center

Tipton, Pennsylvania, United States

Hartwell Research Group

Anderson, South Carolina, United States

Radiant Research, Inc.

Greer, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Comprehensive Pain Specialists, LLC

Hendersonville, Tennessee, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Heartland Medical, PC

New Tazewell, Tennessee, United States

HCCA Clinical Research Solutions

Smyrna, Tennessee, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

KRK Medical Research

Dallas, Texas, United States

Heights Doctor's Clinic

Houston, Texas, United States

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Aspen Clinical Research

Orem, Utah, United States

Advanced Clinical Research

West Jordan, Utah, United States

HypotheTest, LLC

Roanoke, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Washington Center for Pain Management

Edmonds, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26111544 (View on PubMed)

Campbell 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.

Reference Type: DERIVED

PMID: 28072811 (View on PubMed)

Other Identifiers

HYD3002

Identifier Type: -

Identifier Source: org_study_id