Status:
COMPLETED
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Lead Sponsor:
Pfizer
Conditions:
Chronic Noncancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT01428583
Start Date
December 1 2010
End Date
May 1 2012
Last Update
November 21 2016
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
2
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
3
Drug Study Institute
Jupiter, Florida, United States, 33458
4
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States, 32174