Study 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.
Qualified Participants Must:
• Be 18-75 years of age
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Have been diagnosed with 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
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Have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
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Be able to complete study procedures and attend clinic visits for 6 to 12 months
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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
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Have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
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Voluntarily provide written informed consent
Qualified Participants May Receive:
Medical care, medication, and compensation for time and travel.