EUCTR2008-002428-27-DK进行中（未招募）不适用
A multi-centre, open-label, single therapy, dose ranging study to characterise the pharmacokinetics and tolerability of BTDS 5-20 µg/h in children who require opioid analgesia for moderate to severe mouth pain secondary to chemotherapy induced mucositis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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. Male or female children experiencing moderate to severe mouth pain secondary to chemotherapy induced mucositis requiring opioid analgesic therapy and who will be an inpatient, as a minimum up to Day 8 (patch removal)
- •2. Subjects experiencing ‘moderate to severe’ pain in the Investigators clinical judgment
- •3. Body weight = 12kg. Subjects aged = 2 years. Upper age range to be 16 years.
- •4. In dwelling IV cannula or central line from which blood can be obtained
- •5. Written informed consent obtained from parent(s)/legal representative, and where possible assent obtained from the subject if appropriate, in line with local regulations.
- •6. Females of child bearing potential must have a negative urine pregnancy test if the Principal Investigator considers there to be a reasonable possibility of pregnancy.
- •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. Subjects with known hypersensitivity to buprenorphine or any of its excipients in the transdermal system, as outlined in the Summary of Product Characteristics for BuTrans
- •2. Known hypersensitivity to other opioids
- •3. Skin disease affecting application or local tolerance of BTDS
- •4. Clinically significant history of allergic reaction to wound dressings or adhesives
- •5. Severe respiratory impairment
- •6. Clinically significant hepatic dysfunction
- •7. Severe renal impairment
- •8. Subjects who are receiving MAO inhibitors or have taken them within the previous 2 weeks
- •9. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator’s opinion, may pose a risk of additional CNS depression with study medication
- •10. Subjects who have taken any buprenorphine preparations in the last 14 days
- •11. Subjects with myasthenia gravis
- •12. Subjects with convulsive disorders, head injury, shock, or reduced level of consciousness of uncertain origin
- •13. Subjects who are currently participating in another clinical research study involving a new chemical entity (NCE) unless the sole purpose of the other trial at the time of BUP1501 screening is for long term follow-up/survival data or subjects who have participated in a clinical study within the previous 30 days. Participation in a chemotherapy clinical trial that is not evaluating a NCE will be accepted for inclusion
- •14. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving
- •15. Previous enrolment in this clinical study
- •16. Subjects who the Investigator believes are unsuitable for the study.
研究者
相似试验
进行中（未招募）
1 期
A multi-centre, open-label, single therapy, dose ranging study to characterise the pharmacokinetics and tolerability of BTDS 5-20 µg/h in children who require opioid analgesia for moderate to severe mouth pain secondary to chemotherapy induced mucositisModerate to severe mouth pain secondary to chemotherapy induced mucositis requiring opioid analgesic therapy.EUCTR2008-002428-27-GBMundipharma Research Limited25
进行中（未招募）
不适用
To study the effect of two drugs â?? Capecitabine 500 mg (Test product by Reliance Life Sciences Pvt. Ltd., India) and Xeloda® (Capecitabine 500 mg by Roche Pharma AG, Germany)CTRI/2014/10/005130Reliance Life Sciences Pvt Ltd
尚未招募
不适用
A clinical study to demonstrate bioequivalence between two drugs Xeloda (Reference) and Capecitabine 500 mg Tablets (Test) in cancer patientsCTRI/2011/12/002266Reliance Life Sciences Pvt Ltd66
招募中
不适用
Clinical trial to compare two drugs, Temodal and Temozolomide 250 mg capsules in cancer patientsCTRI/2011/12/002274Reliance Life Sciences Pvt Ltd24
进行中（未招募）
1 期
A clinical trial that is optimising 2 radioactive anti-cancer treatments to see if the combination is safe and effective for patients with a form of brain cancer known as GBM.2nd line therapy of recurrent GBM (Glioblastoma multiforme), scheduled for repeat XRT.EUCTR2018-002262-39-ATTELIX International Pty Ltd44