EUCTR2010-020510-29-FI进行中（未招募）不适用
An Open-label Study to Characterise the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release Tablets (ORF) in Paediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Have written informed consent provided by the parent or legal guardian and patient assent, when appropriate.
- •2. Children of either gender, aged 6 to 16 years, inclusive.
- •3. Have or are expected to have moderate to severe pain for an extended period of time requiring inpatient opioid analgesic treatment for at least 12 hours as this is the minimum duration of study period treatment.
- •4. Must be treated with an opioid for a minimum of 96 hours prior to the first dose of ORF.
- •5. In order to receive the first oral dose, patients must have respiratory stability, including a sustained SpO2 of at least 92% with or without supplemental oxygen during the 15 minute period just prior to dosing.
- •6. Must be inpatient for the treatment period of the study.
- •7. The patient’s anticipated opioid analgesic requirement over the first 12 hours that will follow administration of ORF must be equivalent to at least 10 mg of IV morphine.
- •8. Have adequate pain control during the 6 hours prior to study drug administration, based on appropriate clinical assessment.
- •9. Must be sufficiently alert to communicate and complete the FPS-R or 100-mm VAS.
- •10. Females who are sexually active must be using an adequate and reliable method of contraception.
- •11. If female and of child bearing potential, must have a negative pregnancy test and be non-lactating.
- •12. Must be able to swallow tablets whole.
- •13. Must have stable vital signs.
- •14. Must have vascular access to facilitate blood draws.
- •15. Must be willing and able to participate in all aspects of this study involving use of oral medications, patient evaluation, and phlebotomy, as evidenced by written informed consent from the parent or legal guardian and written patient assent when required by the local IRB/EC.
- •16. Must be willing to have up to 10 mL of blood collected for blood analysis (7 mL for primary PK and 3 mL for secondary PK analysis); and up to 10 ml of blood for pre-specified safety laboratory tests, without safety concerns.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who have had surgery within 96 hours prior to the day of first dose of study drug.
- •2. Have any history of hypersensitivity or medical contraindication for the use of oxycodone (this does not exclude patients with a history of expected opioid-related AEs, such as light-headedness, dizziness, sedation, nausea, or vomiting).
- •3. Have any current history of medical or surgical conditions that might significantly interfere with the gastrointestinal absorption, distribution, metabolism, or excretion of oxycodone (this includes any history of serious disease of the gastrointestinal tract, liver, kidneys, and/or blood-forming organs).
- •4. Have received oxycodone in the 24 hours prior to study drug administration. (See Protocol Section 9.9, Excluded, Prior and Concomitant Medications and Therapies).
- •5. Have received epidural (or regional) anesthesia <12 hours prior to the first oral dose of ORF.
- •6. Patients who are cyanotic post-operatively.
- •7. Have a current history of malabsorption syndrome.
- •8. Have a current diagnosis of sleep apnea within the last year.
- •9. Have reduced renal function (serum creatinine > 1.8 X the upper limit of normal for age).
- •10. Have hepatic impairment as evidenced by serum alanine amino transferase (ALT) or serum aspartate amino transferase (AST) > 5 times the upper limit of normal (ULN) for age.
- •11. Are taking moderate to strong CYP3A4 inhibitors if the dose has not been stable for at least 1 month.
- •12. Are taking moderate to strong CYP3A4 inhibitors if the dose has been stable for at least 1 month but the adjusted starting dose determined for ORF is less than 10mg (see Protocol Section 9.7. Dose Conversions, Protocol Section 9.9. Excluded, Prior and Concomitant Medications and Therapies and Appendix I for a list of strong and moderate CYP3A4 inhibitors [as per FDA Guidance, 2006]).
- •13. Patients for whom it is anticipated that therapy with a moderate to strong CYP3A4 inhibitor will be initiated during the study, after the screening visit (see Protocol Section 9.9. Excluded, Prior and Concomitant Medications and Therapies and Appendix I for a list of strong and moderate CYP3A4 inhibitors [as per FDA Guidance, 2006]).
- •14. Have impaired respiratory reserve including severe acute or chronic lung disease, or patients receiving mechanical respiratory support, including mechanical ventilation, BIPAP, or CPAP 6 hours prior to the first oral dose and during the entire oral treatment period.
- •15. Have impaired cardiovascular stability (e.g., the day of surgery for cardiac surgery patients).
- •16. Are currently taking an investigational medication/therapy at the start of screening or during the study.
- •17. Are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.
研究者
相似试验
进行中（未招募）
1 期
An Open-label Study to Characterise the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release Tablets (ORF) in Paediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia.Post operative and non-surgical paediatric patients, expected to or must have moderate to severe pain requiring oral opioid analgesic treatment for at least 24 hours. Patients must be inpatient for the treatment period of the study.MedDRA version: 12.1Level: LLTClassification code 10002182Term: AnalgesiaMedDRA version: 12.1Level: LLTClassification code 10036276Term: Postoperative analgesiaEUCTR2010-020510-29-GBPurdue Pharma L.P.36
已完成
2 期
The safety and effectiveness of testosterone pellet implantation in hypogonadal malesHypogonadismMetabolic and Endocrine - Other metabolic disordersACTRN12614000604606Auxilium Pharmaceuticals, Inc.24
进行中（未招募）
1 期
A study of mepolizumab in children from 6 to 11 years of age with severe asthmaEUCTR2014-002666-76-GBGlaxoSmithKline Research & Development Ltd28
进行中（未招募）
1 期
A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.Rheumatoid arthritisEUCTR2005-003632-22-ESF. Hoffmann-La Roche Ltd.3
已完成
不适用
An Open Label Study to Investigate the Pharmacokinetics (Absorption, Distribution, Metabolism, and Excretion) of Omacetaxine Mepesuccinate Following Subcutaneous Administration of [14C]c in Patients with Relapsed and/or Refractory Hematologic Malignancies or Advanced Solid Tumors.advanced solid tumorsmalignant conditions of the bloodrelapsed and/or refractory hematologic malignanciessolid lumps.10027655NL-OMON40403TEVA Pharma10