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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002235-26 | EudraCT Number |
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The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone HCl controlled-release | Experimental | Oxycodone hydrochloride controlled-release tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone hydrochloride controlled-release tablets | Drug | Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Adverse Events as a Measure of Safety. | Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population. | Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment). |
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Inclusion Criteria include:
Exclusion Criteria include:
Other protocol specific inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Bayview Research Group, LLC |
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| Label | URL |
|---|---|
| Product Information | View source |
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Opioid-experienced pediatric patients with moderate to severe malignant and/or nonmalignant pain requiring around-the-clock opioid therapy were eligible for open-label Extension Study OTR3002 if they completed the 4-week treatment period Core Study OTR3001 and could benefit from continued treatment with oxycodone HCl CR 20 to 240 mg total daily.
First Patient First Visit: 05-January-2012; Last Patient Last Visit: 09-December-2013. The study was conducted at 14 medical/research sites in the United States and Israel.
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 to < 12 Years | Children 6 to < 12 years of age |
| FG001 | ≥ 12 to ≤ 16 Years | Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Paramount |
| California |
| 90723 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Mercy Clinic Children's Cancer and Hematology Center | St Louis | Missouri | 63141 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Presbyterian Blume Pediatric Hematology & Oncology Clinic | Charlotte | North Carolina | 28204 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| The Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Schneider Children Medical Center of Israel | Petah Tikva | 49202 | Israel |
| COMPLETED |
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| NOT COMPLETED |
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The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 to < 12 Years | Children 6 to < 12 years of age |
| BG001 | ≥ 12 to ≤ 16 Years | Children 12 to ≤ 16 years of age |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | The Number of Participants With Adverse Events as a Measure of Safety. | Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population. | The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study. | Posted | Number | participants | Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment). |
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Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
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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 | 6 to < 12 Years | Children 6 to < 12 years of age | 3 | 9 | 8 | 9 | ||
| EG001 | ≥ 12 to ≤ 16 Years | Children ≥ 12 to ≤ 16 years of age | 2 | 14 | 8 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA (13.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA (13.0) | Systematic Assessment |
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| Auricular swelling | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
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| External ear pain | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Mydriasis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Cyst | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Blood magnesium decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Respiratory rate | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Scar | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Scar excision | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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Enrollment for study OTR3002 was closed by Purdue Pharma L.P. on 01-January-2014 due to administrative reasons not related to safety.
Interpretation is limited by the small number of patients in each age group in this study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| 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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| Male |
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| Black or African American |
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