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

This study has been completed.
Sponsor:
Collaborator:
Kendle Early Stages Toronto
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00955110
First received: August 5, 2009
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Oxymorphone ER
Drug: Oxycodone CR
Drug: Placebo
Drug: Hydromorphone
Phase 4

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 78
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955110

Locations
Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Endo Pharmaceuticals
Kendle Early Stages Toronto
  More Information

Additional Information:
No publications provided by Endo Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00955110     History of Changes
Other Study ID Numbers: EN3202-402
Study First Received: August 5, 2009
Results First Received: January 31, 2011
Last Updated: July 5, 2011
Health Authority: Canada: Health Canada

Keywords provided by Endo Pharmaceuticals:
Opioid
Recreational
Oxymorphone
Oxycodone
Extended Release
Healthy NonDependent Recreational Opioid Users

Additional relevant MeSH terms:
Hydromorphone
Oxycodone
Oxymorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on September 30, 2014