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

• Sponsor: Endo Pharmaceuticals
• Collaborator: Kendle Early Stage - Toronto
• Information provided by: Endo Pharmaceuticals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Oxymorphone ER; Drug: Oxycodone CR; Drug: Placebo; Drug: Hydromorphone	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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 Start Date: June 2009
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oxymorphone ER 15 mg; 15mg	Drug: Oxymorphone ER; 15mg or 30mg; Other Name: Opana; Drug: Hydromorphone; 8 mg
Active Comparator: Oxycodone CR 30 mg; 30mg	Drug: Oxycodone CR; 30mg or 60mg; Other Name: Oxycontin; Drug: Hydromorphone; 8 mg
Placebo Comparator: Placebo	Drug: Placebo; The placebo was a sugar pill.; Drug: Hydromorphone; 8 mg
Experimental: Oxymorphone ER 30mg; 30mg	Drug: Oxymorphone ER; 15mg or 30mg; Other Name: Opana; Drug: Hydromorphone; 8 mg
Active Comparator: Oxycodone CR 60mg; 60mg	Drug: Oxycodone CR; 30mg or 60mg; Other Name: Oxycontin; Drug: Hydromorphone; 8 mg

Outcome Measures

Primary Outcome Measures :

1. High VAS - Emax (mm) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

Toronto, Ontario, Canada

Sponsors and Collaborators

Endo Pharmaceuticals

Kendle Early Stage - Toronto

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00955110 History of Changes
• Other Study ID Numbers: EN3202-402
• First Posted: August 7, 2009
• Results First Posted: July 14, 2011
• Last Update Posted: October 5, 2017
• Last Verified: September 2017

Keywords provided by Endo Pharmaceuticals:

Opioid; Recreational; Oxymorphone; Oxycodone; Extended Release; Healthy NonDependent Recreational Opioid Users

Additional relevant MeSH terms:

Analgesics, Opioid; Oxycodone; Hydromorphone; Oxymorphone; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia