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

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Hydromorphone; Drug: Oxycodone CR; Drug: Placebo; Drug: Oxymorphone ER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00955110

EN3202-402

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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78 participants in 5 patient groups, including a placebo group

Oxymorphone ER 15 mg

Experimental group

Description:

15mg

Treatment:

Drug: Oxymorphone ER

Drug: Hydromorphone

Oxycodone CR 30 mg

Active Comparator group

Description:

30mg

Treatment:

Drug: Oxycodone CR

Drug: Hydromorphone

Placebo

Placebo Comparator group

Treatment:

Drug: Hydromorphone

Drug: Placebo

Oxymorphone ER 30mg

Experimental group

Description:

30mg

Treatment:

Drug: Oxymorphone ER

Drug: Hydromorphone

Oxycodone CR 60mg

Active Comparator group

Description:

60mg

Treatment:

Drug: Oxycodone CR

Drug: Hydromorphone