Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
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ClinicalTrials.gov Identifier: NCT00955110 |
Recruitment Status :
Completed
First Posted : August 7, 2009
Results First Posted : July 14, 2011
Last Update Posted : October 5, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Oxymorphone ER Drug: Oxycodone CR Drug: Placebo Drug: Hydromorphone | Phase 4 |
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 |

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 |
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955110
Canada, Ontario | |
Toronto, Ontario, Canada |
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 |
Other Study ID Numbers: |
EN3202-402 |
First Posted: | August 7, 2009 Key Record Dates |
Results First Posted: | July 14, 2011 |
Last Update Posted: | October 5, 2017 |
Last Verified: | September 2017 |
Opioid Recreational Oxymorphone |
Oxycodone Extended Release Healthy NonDependent Recreational Opioid Users |
Oxymorphone Oxycodone Hydromorphone Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia |