Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
NCT ID: NCT01081912
Last Updated: 2022-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
510 participants
INTERVENTIONAL
2010-03-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hydrocodone Bitartrate Capsules
Hydrocodone Bitartrate Controlled-Release Capsules
Hydrocodone bitartrate
dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg
Placebo comparator
Placebo
Capsules, no active substance, shells identical to active comparator capsules
Interventions
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Placebo
Capsules, no active substance, shells identical to active comparator capsules
Hydrocodone bitartrate
dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after lower back pain (LBP) surgery
* Subjects must in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their chronic lower back pain (CLBP).
* Subjects must have been taking opioids for at least 5 days/week for the past 4weeks
* Subjects must have an average Clinic Pain Score of ≥ 4 on the 11-point (0-10) numeric rating scale (NRS) as an average for the last 24 hours of Screening
* Subjects, in the opinion of the Investigator, must be considered to be in generally good health other then CLBP at Screening
* Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
* Subjects must voluntarily provide written informed consent.
Exclusion Criteria
* A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug
* A surgical procedure for back pain within 6 months
* A nerve or plexus block, including epidural steroid injections or facet blocks
* A history of chemotherapy or confirmed malignancy within past 2 years
* Any other chronic pain condition other than CLBP that, in the Investigator's opinion, would interfere with the assessment of LBP e.g. fibromyalgia, osteoarthritis, rheumatoid arthritis, migraine headaches requiring opioid treatment
* Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure \>180 mmHg or \<90 mmHg, and/or a sitting diastolic blood pressure \>120 mmHg or \<50 mmHg at Screening
* A Body Mass Index (BMI) \>45 kg/m2
* A Hospital Anxiety and Depression Scale (HADS) Index score of \>12 in either depression or anxiety subscales or an established history of major depressive disorder that is poorly controlled with medication
* A clinically significant abnormality in clinical chemistry, hematology or urinalysis
18 Years
75 Years
ALL
No
Sponsors
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Zogenix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Romanko, DPM
Role: STUDY_DIRECTOR
Zogenix, Inc.
Locations
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Arizona Research Center
Phoenix, Arizona, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Neuro-Pain Medical Center, Inc.
Fresno, California, United States
Pacific Coast Pain Management Center
Laguna Hills, California, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Interwest Rehabilitation, LLC
Littleton, Colorado, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Peninsula Research, Inc.
Ormond Beach, Florida, United States
Gold Coast Research
Plantation, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Georgia Clinical Research
Snellville, Georgia, United States
Suburban Clinical Research
Chicago, Illinois, United States
Destiny Clinical Research, LLC
Evansville, Indiana, United States
Integrated Clinical Trials Services, Inc.
West Des Moines, Iowa, United States
International Clinical Research Institute
Leawood, Kansas, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Clinical Trials Management
Metairie, Louisiana, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, United States
River Cities Clinical Research Center
Shreveport, Louisiana, United States
NECCR Internal Medicine & Cardiology Associates, LLC
Fall River, Massachusetts, United States
Center for Clinical Trials
Biloxi, Mississippi, United States
Research West, LLC
Kalispell, Montana, United States
Office of Danka Michaels, MD
Las Vegas, Nevada, United States
South Jersey Medical Associates
Blackwood, New Jersey, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
Five Towns Neuroscience Research
Cedarhurst, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Center for Clinical Research LLC
Winston-Salem, North Carolina, United States
IVA Research
Cincinnati, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Neuropsychiatric Research Center
Oklahoma City, Oklahoma, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Feasterville Family Health Care Center
Feasterville, Pennsylvania, United States
New England Center for Clinical Research
Cranston, Rhode Island, United States
Health Concepts
Rapid City, South Dakota, United States
Integrity Clinical Research, LLC
Milan, Tennessee, United States
InSite Clinical Research
DeSoto, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Invisions Consultants, LLC
San Antonio, Texas, United States
Clinical Trial Network
Spring, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Hypothe Test, LLC
Roanoke, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Other Identifiers
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ZX002-0801
Identifier Type: -
Identifier Source: org_study_id
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