Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Completed · Phase 3

Conditions studied: Chronic Noncancer Pain

In brief

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.

Key facts

Study ID

NCT01428583

Run by

Pfizer

People needed

395

Starts

2010-12-01

Expected to finish

2012-05-01

Last updated by the study team

2016-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
• Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

You may not qualify if…

• Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
• Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
• Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
• Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
• Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
• If female, the subject is pregnant or breast-feeding.
• Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
• Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.

Where it is running

• Avail Clinical Research, LLC — DeLand, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Ormond Medical Arts Pharmaceutical Research Center — Ormond Beach, Florida, United States
• Peninsula Research, Inc. — Ormond Beach, Florida, United States
• Accord Clinical Research — Port Orange, Florida, United States
• Sarasota Pain Medicine Research — Sarasota, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Center for Prospective Outcome Studies, Inc. — Atlanta, Georgia, United States
• Drug Studies America — Marietta, Georgia, United States
• Georgia Institute for Clinical Research, LLC — Marietta, Georgia, United States
• The Pain Treatment Center of the Bluegrass — Lexington, Kentucky, United States
• Commonwealth Biomedical Research — Madisonville, Kentucky, United States
• Crossroads Research — Owings Mills, Maryland, United States
• DM Clinical Research — Springfield, Massachusetts, United States
• MAPS Applied Research Center — Edina, Minnesota, United States
• Mid-South Anesthesia Consultants — Southaven, Mississippi, United States
• Healthcare Research, LLC — Hazelwood, Missouri, United States
• Montana Neuroscience Institute — Missoula, Montana, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• Drug Trials America - New York — Hartsdale, New York, United States
• New York Spine and Wellness Center — North Syracuse, New York, United States
• Upstate Clinical Research Associates — Williamsville, New York, United States
• Center for Clinical Research, LLC - Winston-Salem — Winston-Salem, North Carolina, United States
• Columbus Clinical Research, Inc. — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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