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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Oxymorphone ER; Drug: Oxycodone CR; Drug: Placebo; Drug: Hydromorphone

• Registration Number: NCT00955110
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-01-31
• Results First Submitted QC: 2011-07-05
• Results First Posted: 2011-07-14
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxymorphone ER 30mg	Hydromorphone	30mg
Oxymorphone ER 30mg	Oxymorphone ER	30mg
Oxymorphone ER 15 mg	Oxymorphone ER	15mg
Oxymorphone ER 15 mg	Hydromorphone	15mg
Oxycodone CR 30 mg	Oxycodone CR	30mg
Oxycodone CR 30 mg	Hydromorphone	30mg
Placebo	Placebo	-
Placebo	Hydromorphone	-
Oxycodone CR 60mg	Oxycodone CR	60mg
Oxycodone CR 60mg	Hydromorphone	60mg

Primary Outcome Measures

Name	Time	Method
High VAS - Emax (mm)	High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.	The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar ("I am feeling high"). The ends of the line were marked with the descriptive anchors ("Definitely not" and "Definitely so"). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line.