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| Name | Class |
|---|---|
| Kendle Early Stage - Toronto | OTHER |
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The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymorphone ER 15 mg | Experimental | 15mg |
|
| Oxycodone CR 30 mg | Active Comparator | 30mg |
|
| Placebo | Placebo Comparator |
| |
| Oxymorphone ER 30mg | Experimental | 30mg |
|
| Oxycodone CR 60mg | Active Comparator | 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymorphone ER | Drug | 15mg or 30mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21102969 | Derived | 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. |
| Label | URL |
|---|---|
| Reduced Cognitive and Psychomotor Impairment with Extended-Release Oxymorphone Versus Controlled-Release Oxycodone | View source |
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A double-blind crossover qualification phase (hydromorphone 8 mg vs. placebo) was followed by a washout period and then randomization to a 5-period, 10-sequence crossover treatment phase. Approximately 40 qualified subjects were to be enrolled in the treatment phase in order to ensure that at least 30 subjects completed all 5 periods of the study.
The period of recruitment was from 29 May 2009 (first subject enrolled) to 01 September 2009 (last subject completed).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Subjects enrolled were healthy non-dependent recreational opioid users. During the Treatment Phase, subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg. All participants did not necessarily receive the 5 drug interventions in the order reported as Milestones. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Qualification Phase |
|
| ||||||||||||||||||
| Treatment Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Randomized to Treatment Phase | Forty one (41) qualified subjects were randomized into the treatment phase (Randomized population). Subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | mm | High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose. |
|
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).
AEs were any new (or increased severity of) signs, symptoms, injury, or illness. Conditions existing prior to screening were recorded as the subject's medical history; events occurring from screening until first dose of study drug in the qualification phase were recorded as baseline signs and symptoms. AEs were reported for the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Phase Placebo | Identical placebo capsules using size AA Swedish orange capsules and microcrystalline cellulose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA] version 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals, Inc. | clinicalsite.inquiries@endo.com |
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| ID | Term |
|---|---|
| D010111 | Oxymorphone |
| D010098 | Oxycodone |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Oxycodone CR | Drug | 30mg or 60mg |
|
|
| Placebo | Drug | The placebo was a sugar pill. |
|
| Hydromorphone | Drug | 8 mg |
|
| Oxymorphone ER 30 mg |
|
| Oxycodone CR 30 mg |
|
| Oxycodone CR 60 mg |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Subjects received a single oral dose (1 capsule) of placebo. |
| OG001 | Oxymorphone ER 15 mg | Subjects received a single oral dose (1 capsule) of Oxymorphone ER 15 mg. |
| OG002 | Oxymorphone ER 30 mg | Subjects received a single oral dose (1 capsule) of Oxymorphone ER 30 mg. |
| OG003 | Oxycodone CR 30 mg | Subjects received a single oral dose (1 capsule) of Oxycodone CR 30 mg. |
| OG004 | Oxycodone CR 60 mg | Subjects received a single oral dose (1 capsule) of Oxycodone CR 60 mg. |
|
|
|
| 0 |
| 38 |
| 13 |
| 38 |
| EG001 | Treatment Phase Oxymorphone ER 15 mg | Single oral dose (1 capsule) of Oxymorphone HCl ER 15 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill. | 0 | 37 | 22 | 37 |
| EG002 | Treatment Phase Oxymorphone ER 30mg | Single oral dose (1 capsule) of Oxymorphone HCl ER 30 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill. | 0 | 38 | 28 | 38 |
| EG003 | Treatment Phase Oxycodone CR 30mg | Single oral dose (1 capsule) of Oxycodone HCl CR 30 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill. | 0 | 40 | 35 | 40 |
| EG004 | Treatment Phase Oxycodone CR 60 mg | Single oral dose (1 capsule) of Oxycodone HCl CR 60 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill. | 0 | 40 | 39 | 40 |
| Nausea | Gastrointestinal disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Feeling of relaxation | General disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA] version 11.0 | Non-systematic Assessment |
|
Any analysis and/or publication of any data generated or arising from the study is not permitted without the prior written consent of Endo Pharmaceuticals Inc.
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003061 | Codeine |