Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
NCT ID: NCT01115569
Last Updated: 2022-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
424 participants
INTERVENTIONAL
2010-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hydrocodone Bitartrate
Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Hydrocodone Bitartrate
Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
Interventions
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Hydrocodone Bitartrate
Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
* Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months
* Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
* Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
* 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 study drug
* A surgical procedure for pain within the last 3 months
* Uncontrolled blood pressure, i.e., a sitting systolic blood pressure \>180 mm Hg or \<90 mm Hg, and/or a sitting diastolic blood pressure \>120 mm Hg or \<50 mm Hg at Screening
* A body mass index (BMI) \> 45 kg/m2
* A hospital anxiety and depression scale (HADS) score of \>12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled
* 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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Vickie Gorgone
Role: STUDY_DIRECTOR
Zogenix, Inc.
Locations
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Arizona Research Center
Phoenix, Arizona, United States
HOPE Research Institute, LLC
Phoenix, Arizona, United States
Cochise Clinical Research
Sierra Vista, Arizona, United States
Ortho Research
Little Rock, Arkansas, United States
Pain Institute of California
Bakersfield, California, United States
Providence Clinical Research
Burbank, California, United States
South Orange County Surgical Medical Group
Laguna Hills, California, United States
Scripps Clinic, Clinical Research
San Diego, California, United States
Mountain View Clinical Research, Inc.
Golden, Colorado, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Gold Coast Research, LLC
Plantation, Florida, United States
Advanced Research Institute, Inc.
Trinity, Florida, United States
National Pain Research Institute, Inc.
Winter Park, Florida, United States
Best Clinical Research
Decatur, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Better Health Clinical Research, Inc
Newnan, Georgia, United States
Nautical Clinical Research, LLC
Boise, Idaho, United States
Suburban Clinical Research
Bolingbrook, Illinois, United States
International Clinical Research Institute, Inc.
Leawood, Kansas, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Clinical Trials Managements, LLC
Mandeville, Louisiana, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC
Fall River, Massachusetts, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, United States
Mid-South Anesthesia Consultants
Southaven, Mississippi, United States
Clinvest
Springfield, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Research West, LLC
Kalispell, Montana, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
New York University Pain Management Center
New York, New York, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Valley Medical Group, PC
Centerville, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Hometown Urgent Care and Research
Springfield, Ohio, United States
Hillcrest Clinical Research, Inc.
Oklahoma City, Oklahoma, United States
Memorial Clinical Research DBA Angelique Barreto, MD
Oklahoma City, Oklahoma, United States
Blair Medical Associates
Altoona, Pennsylvania, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
New England Center for Clinical Research, Inc.
Cranston, Rhode Island, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, United States
The Clinical Research Center, LLC
Fort Worth, Texas, United States
Heights Doctors Clinic
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
West Side Medical
Clinton, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Advanced Pain Management
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Other Identifiers
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ZX002-0802
Identifier Type: -
Identifier Source: org_study_id
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