Expired Study
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Clinical Trial 9295

Burbank, CA 91505


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
• 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
• Have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
• 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
• Have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
• Voluntarily provide written informed consent


Qualified Participants May Receive:

Medical care, medication, and compensation for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.