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Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Oxymorphone ER (Drug); Oxycodone CR (Drug); Placebo (Drug); Hydromorphone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Endo Pharmaceuticals


The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).

Clinical Details

Official title: An Exploratory, Single-Dose, Double-Blind, Randomized, Placebo-Controlled Crossover Study to Evaluate The Subjective and Objective Effects of Extended-Release Oxymorphone Compared to Controlled-Release Oxycodone in Healthy Non-Dependent Recreational Opioid Users

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: High VAS - Emax (mm)


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Recreational opioid use.

- 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:

- Self-reported history of drug or alcohol dependence in the past 2 years or presence

of drug or alcohol dependence in the past 12 months as defined by the DSM-IV, including subjects who have ever been in a drug rehabilitation program.

- Unwillingness or inability to abstain from recreational drug use as required for the


- 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.

Locations and Contacts

Toronto, Ontario, Canada
Additional Information

Reduced Cognitive and Psychomotor Impairment with Extended-Release Oxymorphone Versus Controlled-Release Oxycodone

Starting date: June 2009
Last updated: July 5, 2011

Page last updated: August 23, 2015

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