Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain
1 other identifier
interventional
424
1 country
50
Brief Summary
This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-pain
Started May 2010
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
April 25, 2014
CompletedNovember 9, 2022
March 1, 2014
1.7 years
April 30, 2010
February 4, 2014
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Average Daily Pain
Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.
1 year
Secondary Outcomes (1)
Maintenance of Efficacy
1 year
Study Arms (1)
Hydrocodone Bitartrate
EXPERIMENTALOpen-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Interventions
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
Eligibility Criteria
You may qualify if:
- Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain
- 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
You may not qualify if:
- Any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (AEs)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zogenix, Inc.lead
Study Sites (50)
Arizona Research Center
Phoenix, Arizona, 85023, United States
HOPE Research Institute, LLC
Phoenix, Arizona, 85050, United States
Cochise Clinical Research
Sierra Vista, Arizona, 85635, United States
Ortho Research
Little Rock, Arkansas, 72205, United States
Pain Institute of California
Bakersfield, California, 93311, United States
Providence Clinical Research
Burbank, California, 91505, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
Scripps Clinic, Clinical Research
San Diego, California, 92128, United States
Mountain View Clinical Research, Inc.
Golden, Colorado, 80401, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Advanced Research Institute, Inc.
Trinity, Florida, 34655, United States
National Pain Research Institute, Inc.
Winter Park, Florida, 32789, United States
Best Clinical Research
Decatur, Georgia, 30034, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Better Health Clinical Research, Inc
Newnan, Georgia, 30265, United States
Nautical Clinical Research, LLC
Boise, Idaho, 83702, United States
Suburban Clinical Research
Bolingbrook, Illinois, 60490, United States
International Clinical Research Institute, Inc.
Leawood, Kansas, 66211, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206, United States
Clinical Trials Managements, LLC
Mandeville, Louisiana, 70471, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, 71101, United States
New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC
Fall River, Massachusetts, 02720, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, 02747, United States
Mid-South Anesthesia Consultants
Southaven, Mississippi, 38671, United States
Clinvest
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Research West, LLC
Kalispell, Montana, 59901, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
New York University Pain Management Center
New York, New York, 10016, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Valley Medical Group, PC
Centerville, Ohio, 45459, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Hometown Urgent Care and Research
Springfield, Ohio, 45504, United States
Hillcrest Clinical Research, Inc.
Oklahoma City, Oklahoma, 73119, United States
Memorial Clinical Research DBA Angelique Barreto, MD
Oklahoma City, Oklahoma, 73134, United States
Blair Medical Associates
Altoona, Pennsylvania, 16602, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
New England Center for Clinical Research, Inc.
Cranston, Rhode Island, 02920, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, 75235, United States
The Clinical Research Center, LLC
Fort Worth, Texas, 76104, United States
Heights Doctors Clinic
Houston, Texas, 77008, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
West Side Medical
Clinton, Utah, 84015, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Advanced Pain Management
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Romanko
- Organization
- Zogenix
Study Officials
- STUDY DIRECTOR
Vickie Gorgone
Zogenix, Inc.
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
April 30, 2010
First Posted
May 4, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 9, 2022
Results First Posted
April 25, 2014
Record last verified: 2014-03