Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
NCT ID: NCT00955110
Last Updated: 2017-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2009-06-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Oxymorphone ER 15 mg
15mg
Oxymorphone ER
15mg or 30mg
Hydromorphone
8 mg
Oxycodone CR 30 mg
30mg
Oxycodone CR
30mg or 60mg
Hydromorphone
8 mg
Placebo
Placebo
The placebo was a sugar pill.
Hydromorphone
8 mg
Oxymorphone ER 30mg
30mg
Oxymorphone ER
15mg or 30mg
Hydromorphone
8 mg
Oxycodone CR 60mg
60mg
Oxycodone CR
30mg or 60mg
Hydromorphone
8 mg
Interventions
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Oxymorphone ER
15mg or 30mg
Oxycodone CR
30mg or 60mg
Placebo
The placebo was a sugar pill.
Hydromorphone
8 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 3 lifetime occasions of recreational use of an oral intact modified-release opioid product.
* BMI within range of 19.0 to 29.9 kg/m2, inclusive, minimum weight of 50.0 kg at screening and Day 0 of treatment period 1
Exclusion Criteria
* Unwillingness or inability to abstain from recreational drug use as required for the study.
* History of acute asthma or other obstructive airway disease or any condition that may increase the risk for respiratory depression, judged as clinically significant by the investigator or designee.
* History of neurologic conditions such as convulsive disorders or severe head injury, judged as clinically significant by the investigator or qualified designee.
* History of Addison's disease, hypothyroidism, pancreatitis, prostatic hypertrophy, or urethral stricture.
* Use of non-prescription or prescription medications or natural health products within 7 days prior to first drug administration in the qualification phase and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject.
* Uses of Monoamine oxidize inhibitors (MAOIs) within 14 days of first drug administration in the qualification phase and throughout the study.
* Current consumption of greater than 20 cigarettes (or 2 cigars) per day or inability to abstain from smoking (or use of any nicotine-containing sub stance) for at least 14 hours.
18 Years
55 Years
ALL
Yes
Sponsors
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Kendle Early Stage - Toronto
OTHER
Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Endo Pharmaceuticals
Locations
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Toronto, Ontario, Canada
Countries
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References
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Schoedel KA, McMorn S, Chakraborty B, Zerbe K, Sellers EM. Reduced cognitive and psychomotor impairment with extended-release oxymorphone versus controlled-release oxycodone. Pain Physician. 2010 Nov-Dec;13(6):561-73.
Related Links
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Reduced Cognitive and Psychomotor Impairment with Extended-Release Oxymorphone Versus Controlled-Release Oxycodone
Other Identifiers
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EN3202-402
Identifier Type: -
Identifier Source: org_study_id