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

NCT00955110 | Completed Phase 4 Results

• 1 other identifier: EN3202-402
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• High VAS - Emax (mm)

  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.

  High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.

Study Arms (5)

Oxymorphone ER 15 mg

EXPERIMENTAL

15mg

Drug: Oxymorphone ER; Drug: Hydromorphone

Oxycodone CR 30 mg

ACTIVE COMPARATOR

30mg

Drug: Oxycodone CR; Drug: Hydromorphone

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Hydromorphone

Oxymorphone ER 30mg

EXPERIMENTAL

30mg

Drug: Oxymorphone ER; Drug: Hydromorphone

Oxycodone CR 60mg

ACTIVE COMPARATOR

60mg

Drug: Oxycodone CR; Drug: Hydromorphone

Interventions

Oxymorphone ER DRUG

15mg or 30mg

Also known as: Opana

Oxymorphone ER 15 mg; Oxymorphone ER 30mg

Oxycodone CR DRUG

30mg or 60mg

Also known as: Oxycontin

Oxycodone CR 30 mg; Oxycodone CR 60mg

Placebo DRUG

The placebo was a sugar pill.

Placebo

Hydromorphone DRUG

8 mg

Oxycodone CR 30 mg; Oxycodone CR 60mg; Oxymorphone ER 15 mg; Oxymorphone ER 30mg; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead
• Kendle Early Stage - Toronto: collaborator

Study Sites (1)

Unknown Facility

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 21102969 DERIVED

Related Links

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

MeSH Terms

Interventions

Oxymorphone; Oxycodone; Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 5, 2017
• Results First Posted: July 14, 2011

Record last verified: 2017-09

Locations

CA (1)