Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
This study has been completed.
Sponsor:
Endo Pharmaceuticals
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Hydromorphone hydrochloride
Oxymorphone
Oxycodone
Oxycodone hydrochloride
Oxymorphone hydrochloride
Hydromorphone
U.S. FDA Resources
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
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 Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on May 16, 2013