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When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymorphone IR | Experimental | Open-Label, 2 part ascending-dose multicenter study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymorphone IR | Drug | Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet | Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination |
| Subjects Taking Rescue Medication | Percentages are based on the number of subjects in each treatment group. | first dose through 48 hours after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) of Single Dose of Oxymorphone by Treatment Group | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Stanford University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Dose of Oxymorphone IR: 5mg Tablet | |
| FG001 | Single Dose of Oxymorphone IR: 10mg Tablet | |
| FG002 | Single Dose of Oxymorphone IR: 15mg Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration |
| Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| Cmax of Single Dose of Oxymorphone by Treatment Group | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| Tmax of Single Dose of Oxymorphone by Treatment Group | Tmax: The time at which Cmax was observed | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group | λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only) | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| Terminal Half-life of Single Dose of Oxymorphone by Treatment Group | t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only) | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| Stanford |
| California |
| 94305 |
| United States |
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
| Children's Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| St. Joseph's Children's Hospital of Tampa | Tampa | Florida | 33607 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| The Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| FG003 | Multiple Dose of Oxymorphone: 5mg Tablet |
| FG004 | Multiple Dose of Oxymorphone IR: 10mg Tablet |
| FG005 | Multiple Dose of Oxymorphone IR: 15mg Tablet |
| COMPLETED |
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| NOT COMPLETED |
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ITT Population; Single Dose Total = 33; Multiple Dose Total = 25;
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Dose of Oxymorphone IR: 5mg Tablet | |
| BG001 | Single Dose of Oxymorphone IR: 10mg Tablet | |
| BG002 | Single Dose of Oxymorphone IR: 15mg Tablet | |
| BG003 | Multiple Dose of Oxymorphone IR: 5mg Tablet | |
| BG004 | Multiple Dose of Oxymorphone IR: 10mg Tablet | |
| BG005 | Multiple Dose of Oxymorphone IR: 15mg Tablet | |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Single Dose of Oxymorphone IR Overall (N=33): Mean 14.9 SD (1.64) Multiple Dose of Oxymorphone IR Overall (N=25): Mean 15.2 SD (1.13) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet | Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet | ITT Population | Posted | Mean | Standard Deviation | mm | Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Subjects Taking Rescue Medication | Percentages are based on the number of subjects in each treatment group. | Safety Population | Posted | Count of Participants | Participants | first dose through 48 hours after first dose |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | AUC(0-t) of Single Dose of Oxymorphone by Treatment Group | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Posted | Mean | Standard Deviation | ng*hr/mL | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| |||||||||||||||||||||||||||||||||||||
| Secondary | AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group | AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Posted | Mean | Standard Deviation | ng*hr/mL | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of Single Dose of Oxymorphone by Treatment Group | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Posted | Mean | Standard Deviation | ng/mL | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Tmax of Single Dose of Oxymorphone by Treatment Group | Tmax: The time at which Cmax was observed | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Posted | Mean | Standard Deviation | hour | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group | λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only) | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Posted | Mean | Standard Deviation | Time -1 | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
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| Secondary | Terminal Half-life of Single Dose of Oxymorphone by Treatment Group | t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only) | PK Population (only including subjects with sufficient evaluable time points for this outcome measure). | Posted | Mean | Standard Deviation | hour | Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h |
|
All AEs (Single Dose and Multiple Dose) were collected by the investigator starting 15 minutes after the first dose through the end of the study evaluation (24 hours post-first dose or early termination for Single Dose and 48 hours post first dose or early termination for Multiple Dose) and for up to 30 days after the last dose of study medication; this included any AEs that were ongoing at the completion/termination of the study.
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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 | Single Dose of Oxymorphone IR: 5mg Tablet | 0 | 13 | 0 | 13 | 3 | 13 | |
| EG001 | Single Dose of Oxymorphone IR: 10mg Tablet | 0 | 9 | 1 | 9 | 4 | 9 | |
| EG002 | Single Dose of Oxymorphone IR: 15mg Tablet | 0 | 11 | 1 | 11 | 7 | 11 | |
| EG003 | Multiple Dose of Oxymorphone IR: 5mg Tablet | 0 | 9 | 1 | 9 | 8 | 9 | |
| EG004 | Multiple Dose of Oxymorphone IR: 10mg Tablet | 0 | 8 | 1 | 8 | 5 | 8 | |
| EG005 | Multiple Dose of Oxymorphone IR: 15mg Tablet | 0 | 8 | 0 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.1 | Systematic Assessment |
| |
| Fat embolism | Injury, poisoning and procedural complications | MedDRA, Version 11.1 | Systematic Assessment |
| |
| Failure of implant | Injury, poisoning and procedural complications | MedDRA, Version 11.1 | Systematic Assessment |
| |
| Pupils unequal | Eye disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Somatosensory evoked | Investigations | MedDRA, Version 11.1 | Systematic Assessment |
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| Monoplegia | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
| |
| Spinal cord oedema | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA, Version 11.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA, Version 11.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 11.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 11.1 | Systematic Assessment |
|
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saji Vijayan | Endo Pharmaceuticals | (800) 462-3636 | ClinicalTrials@Endo.com |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 30 Minutes Post Dose/30 Minutes Post First Dose |
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| 1 Hour Post Dose/1 Hour Post First Dose |
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| 2 Hours Post Dose/2 Hours Post First Dose |
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| 3 Hours Post Dose/3 Hours Post First Dose |
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| 4 Hours Post Dose/4 Hours Post First Dose |
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| 6 Hrs Post Dose or Rescue/6 Hours Post First Dose |
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| Multiple Dose #1 |
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| Multiple Dose #2 |
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| Multiple Dose #3 |
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| Multiple Dose #4 |
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| Multiple Dose #5 |
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| Multiple Dose #6 |
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| Multiple Dose #7 |
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| Multiple Dose #8 |
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| Multiple Dose #9 |
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| Multiple Dose #10 |
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| Multiple Dose #11 |
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| Early Termination |
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| OG005 | Multiple Dose of Oxymorphone IR: 15mg Tablet | Subjects With at Least One Rescue Medication |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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