HealthyPhase 4NCT00955110

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

A Phase 4 study testing Oxymorphone ER, Oxycodone CR and Hydromorphone in people with Healthy, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Oxymorphone ER, Oxycodone CR and Hydromorphone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 1 siteCanada
Study dates: Jun 2009to Sep 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Study site
Toronto, Ontario

Other trials in Canada

About this study

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

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

Conditions: Healthy
Being tested: Oxymorphone ER, Oxycodone CR, Placebo, Hydromorphone
Keywords: Opioid, Recreational, Oxymorphone, Oxycodone, Extended Release, Healthy NonDependent Recreational Opioid Users

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxymorphone ERDrug
Also called Opana
15mg or 30mg
Oxycodone CRDrug
Also called Oxycontin
30mg or 60mg
PlaceboDrug
The placebo was a sugar pill.
HydromorphoneDrug
8 mg

Study groups in NCT00955110
Study group	Role	What they receive
Oxymorphone ER 15 mg	Experimental	15mg Receives: Drug: Oxymorphone ER; Drug: Hydromorphone
Oxycodone CR 30 mg	Active comparator	30mg Receives: Drug: Oxycodone CR; Drug: Hydromorphone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Hydromorphone
Oxymorphone ER 30mg	Experimental	30mg Receives: Drug: Oxymorphone ER; Drug: Hydromorphone
Oxycodone CR 60mg	Active comparator	60mg Receives: Drug: Oxycodone CR; Drug: Hydromorphone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Sep 2009

First posted7 Aug 2009 (estimated)
Study startJun 2009
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00955110
Sponsor's protocol ID: EN3202-402
Status last verified: Sep 2017
First submitted: 5 Aug 2009
Last updated: 5 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21102969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00955110
Acronym / sponsor ID: EN3202-402
Conditions: Healthy
Keywords: Opioid, Recreational, Oxymorphone, Oxycodone, Extended Release, Healthy NonDependent Recreational Opioid Users
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Collaborators: Kendle Early Stage - Toronto
Study start: Jun 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 7 Aug 2009 (estimated)
Results: Posted 14 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Oxymorphone ER 15 mg	Experimental	Drug: Oxymorphone ER, Drug: Hydromorphone15mg
Oxycodone CR 30 mg	Active comparator	Drug: Oxycodone CR, Drug: Hydromorphone30mg
Placebo	Placebo comparator	Drug: Placebo, Drug: Hydromorphone
Oxymorphone ER 30mg	Experimental	Drug: Oxymorphone ER, Drug: Hydromorphone30mg
Oxycodone CR 60mg	Active comparator	Drug: Oxycodone CR, Drug: Hydromorphone60mg

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxymorphone ERAlso: Opana15mg or 30mg	Drug	Oxymorphone ER 15 mg, Oxymorphone ER 30mg
Oxycodone CRAlso: Oxycontin30mg or 60mg	Drug	Oxycodone CR 30 mg, Oxycodone CR 60mg
PlaceboThe placebo was a sugar pill.	Drug	Placebo
Hydromorphone8 mg	Drug	Oxycodone CR 30 mg, Oxycodone CR 60mg, Oxymorphone ER 15 mg, Oxymorphone ER 30mg, Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 14 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	78	54

Primary outcome: 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.. Mean (Standard Deviation). Unit: mm

Measure	Placebo n = 35	Oxymorphone ER 15 mg n = 35	Oxymorphone ER 30 mg n = 35	Oxycodone CR 30 mg n = 35	Oxycodone CR 60 mg n = 35
Value	23.1 (33.29)	30.6 (36.17)	62.5 (33.22)	81.4 (23.17)	93.0 (12.94)

Oxymorphone ER 30 mg vs Oxycodone CR 60 mg: Least Square Means Difference: -28.8 (95% CI -41.6 to -16.0), p <0.001, ANCOVA
Oxymorphone ER 15 mg vs Oxycodone CR 30 mg: Least Square Mean Difference: -50.5 (95% CI -63.4 to -37.5), p <0.001, ANCOVA
Placebo vs Oxymorphone ER 15 mg: Least Square Mean Difference: 5.5 (95% CI -7.3 to 18.3), p = 0.395, ANCOVA

Population analysed: Per Protocol population: Subjects who received all 5 treatments and who had no major protocol deviations or other circumstances that would exclude them from the analysis. The pharmacokinetic and pharmacodynamic analyses were performed using the Per Protocol population. No imputation of missing values was performed.

Adverse events

Time frame: AEs were documented in the eCRF and/or source documents, whether considered treatment-related or not related, throughout the study (ie, from first dose of study drug in the qualification phase to 30 days following the last dose of study drug).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Phase Placebo	0 of 38 (0%)	13 of 38 (34.2%)	Not reported
Treatment Phase Oxymorphone ER 15 mg	0 of 37 (0%)	22 of 37 (59.5%)	Not reported
Treatment Phase Oxymorphone ER 30mg	0 of 38 (0%)	28 of 38 (73.7%)	Not reported
Treatment Phase Oxycodone CR 30mg	0 of 40 (0%)	35 of 40 (87.5%)	Not reported
Treatment Phase Oxycodone CR 60 mg	0 of 40 (0%)	39 of 40 (97.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21102969Schoedel 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.
Reduced Cognitive and Psychomotor Impairment with Extended-Release Oxymorphone Versus Controlled-Release OxycodoneLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxymorphone ER, Oxycodone CR and Hydromorphone in people with Healthy, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00955110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.