EUCTR2013-003935-32-NO进行中（未招募）1 期
A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages = 6 Months to < 18 Years Receiving Treatment with Opioids
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- •- Patients between the ages of = 6 months and < 18 years.
- •- Patients with malignant or non-malignant pain who are receiving (or are about to receive) acute or chronic treatment with opioids.
- •- In the investigator’s judgment, patients must be either newly diagnosed with constipation or patients must have a history of constipation treated with laxatives or are expected to develop constipation after initiation of opioid treatment.
- •- Female patients of childbearing potential must have a negative urine pregnancy test at screening. Females of childbearing potential must either not be sexually active or be using an adequate birth control method throughout the duration of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Involvement of a parent or guardian in the planning and/or conduct of the study (applies to both KKI staff and/or staff at the study site).
- •2. Previous enrolment in the present study with intake of naloxegol investigational product.
- •3. Current acute or chronic use of methadone.
- •4. For patients 6-12 months old, history of major corrective or reconstructive gastrointestinal surgery (except pyloric stenosis) in the last 6 months or possible need for corrective or reconstructive gastrointestinal surgery in the next month, or history of post-surgical ileus. For patients over 1 year of age, history of previous gastrointestinal surgery in the last 6 months (does not include placement of enteral tubes or liver biopsies).
- •5. History of an intra-abdominal or peritoneal neoplasm or an ongoing GI-related issue (e.g., inflammatory bowel disease, connective tissue disorders like Ehler Danlos, dermatomyositis, scleroderma) which, in the opinion of the investigator, may be contributing to constipation as a result of mechanical obstruction or may place the patient at increased risk for intestinal perforation by impairing the local or global structural integrity of the GI tract.
- •6. Signs or symptoms of GI obstruction including faecal impaction requiring medical intervention. History of GI obstructive conditions (e.g. Hirschsprung’s disease, malrotation, volvulus, pseudo-obstruction syndromes).
- •7. Currently active medical conditions or ongoing treatments (e.g. irinotecan) that may result in diarrhoea or intermittent loose stools during the screening or treatment period.
- •8. Significant cardiorespiratory dysfunction or haemodynamic instability.
- •9. Evidence of known widespread cancer metastases in the CNS.
- •10. Radiotherapy between the diaphragm and the pelvis in the 4 weeks prior to screening or planned to be initiated during the treatment period.
- •11. Any of the following findings and/or conditions:
- •(a) For patients 6 -12 months old, any elevation of serum direct or indirect bilirubin and/or elevation of LFTs not associated with their underlying disease and associated treatment that have not undergone a medical work up. For patients over 1 year old, serum ALT or AST >2.5 x upper limit of normal (ULN) and/or serum bilirubin >1.2 x ULN (unless known to be due to Gilbert’s syndrome or sickle-cell disease).
- •(b)Creatinine clearance less than 60 ml/min/1.73 m2 (using the Schwartz formula).
- •(c) Absolute neutrophil count (ANC) <1.0 x 10^9/L; haemoglobin <9 g/dL (or <7 g/dL if known to be related to sickle cell disease) or, platelet count < 50,000/uL at the time of the first dose of naloxegol. For oncology patients, excursions below these limits may be considered on a case-by-case basis following discussions between the investigator and the Medical Monitor and the agreement of the Sponsor.
- •12. History (within past 3 months) of prolonged (> 10 days) neutropenia or thrombocytopenia with clinical sequelae.
- •13. Treatment with another experimental medication for which there is no current labelled therapy (adult or paediatric), currently or within the last 30 days.
- •14. Patients with cancer currently receiving the first cycle of chemotherapy, or due to receive a chemotherapeutic agent for the first time.
- •15. Life expectancy of < 3 months.
- •16. Treatment within 7 days of naloxegol dosing with any concomitant medications
- •known or expected to be significantly affected by naloxegol administration or
- •known to significantly affect naloxegol PK (See Section 7.7.2 for list
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