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Terminated new protocol developed which incorporated Pharmacokinetics
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Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymorphone ER | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymorphone ER | Drug | Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose | Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken | Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Director CR&D | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine | Little Rock | Arkansas | 72202 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxymorphone ER | Oxymorphone ER dosage was adjusted by investigator during the titration period. Study was terminated early by the Sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period |
|
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| Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose | Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues | Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses | Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| Stanford University School of Medicine |
| Stanford |
| California |
| 94305 |
| United States |
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | United States |
| Tukoi Clinical Research | Miami | Florida | 34104 | United States |
| St. Joseph's Children's Hospital of Tampa | Tampa | Florida | 33618 | United States |
| Taylor Research, LLC | Marietta | Georgia | 30060 | United States |
| Rehabilitation Associates of Indiana | Indianapolis | Indiana | 46250 | United States |
| University of Louisville Reserach Foundation, Inc. | Louisville | Kentucky | 40202 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Hershey Medical Center | Hershey | Pennsylvania | 17112 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Period |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxymorphone ER | Open-label dose titration period of up to 4 weeks and open-label maintenance period of up to 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 |
|
| 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 | Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose | Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Safety population defined as all participants that took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mg | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken | Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Safety population defined as all participants that took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Tablets | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
|
| |||||||||||||||||||||||||||||
| Secondary | Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose | Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Safety population defined as all participants that took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mg | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| ||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues | Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Safety population defined as all participants that took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Rescue doses/day | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
| ||||||||||||||||||||||||||||||
| Secondary | Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses | Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons. | Safety population defined as all participants that took at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Total number of doses | Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) |
|
First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
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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 | Titration Period | Open-label dose titration period of up to 4 weeks | 0 | 27 | 0 | 27 | 15 | 27 |
| EG001 | Maintenance Period | Open-label maintenance period of up to 12 weeks plus 30 days post-last dose | 0 | 24 | 3 | 24 | 7 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anemia with crisis | Congenital, familial and genetic disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Acute pancreatitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Increased alanine aminotransferase | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Increased aspartate aminotransferase | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pouchitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saji Vijayan, MBBS | Endo Pharmaceuticals | 800-462-3636 | clinicaltrials@endo.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010111 | Oxymorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| 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 |
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| Unknown or Not Reported |
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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 |
|
| Unknown or Not Reported |
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