EUCTR2007-005382-35-FI进行中（未招募）不适用
A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate the Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy. - FINDS: Fentanyl In Neoplastic Disease Safety
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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. Age 18 years or older.
- •2. A medically documented diagnosis of cancer.
- •3. Use of a fixed around-the-clock dose of opioid or a fixed combination of opioids as maintenance therapy for pain relief with a dose equivalent of at least 60 mg of oral morphine/day, or at least 25 µg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily or at least 8 mg of oral hydromorphone daily. Current opioid treatment for at least 7 days prior to the randomization.
- •4. Current use of opioid medication for BTP.
- •5. At least 4 episodes of BTP per Week with peak intensity of at least 4 on the numerical pain scale (NPS) at pain onset. No more than 4 BTP episodes per Day.
- •6. The flow rate of inhalation of at least 20 L/min assessed by inspiratory flow meter (the highest of two readings will be used).
- •7. Karnofsky Performance Status 40 or better.
- •8. Life expectancy of at least 12 weeks.
- •9. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Uncontrolled or rapidly increasing BTP.
- •2. Symptomatic intracranial tumors or cerebral metastases.
- •3. Persistent, symptomatic asthma despite medication, as defined by daily symptoms, frequent exacerbations, frequent nocturnal asthma symptoms, predicted FEV1 < 60% or personal best PEFR < 60%.
- •4. Patients unable to use the inhaler (based on investigator’s opinion).
- •5. Inadequate lung function, as defined by PEFR < 60 %.
- •6. Hypersensitivities, allergies or contraindications to fentanyl or the study medication components.
- •7. A recent history of alcohol or substance abuse (in the past 1 year).
- •8. Radiotherapy to the thorax within 30 days of the beginning of the titration phase.
- •9. Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the patient to complete the assessments.
- •10. Participation in any clinical study with an experimental drug within 30 days of the randomization.
- •11. Any clinical condition (e.g. severe hepatic impairment) or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of maintenance opioid therapy).
- •12. Pre-menopausal women (last menstruation < 1 year prior to the screening visit) who:
- •- are not surgically sterile and/or
- •- have a positive pregnancy test at baseline visit and/or
- •- are of childbearing potential and are not using reliable means of birth control or do not plan to continue using this method throughout the study and/or are nursing.
研究者
相似试验
进行中（未招募）
不适用
A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group 12-Week Trial to Evaluate the Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy. - FINDS3Breakthrough pain in opioid tolerant cancer patientsMedDRA version: 11.0Level: LLTClassification code 10064556Term: <Manually entered code. Term in E.1.1>EUCTR2008-007964-40-FIAKELA Pharma Inc.500
尚未招募
3 期
A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate the Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy"CTRI/2009/091/000244Akela Pharma INC500
进行中（未招募）
不适用
A clinical research study to evaluate the impact of the experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women.The impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women (contraceptive).MedDRA version: 14.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-002602-78-ITTEVA WOMEN'S HEALTH RESEARCH&DEVELOPMENT, A DIVISION OF TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.240
进行中（未招募）
不适用
A clinical research study to evaluate the impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women.EUCTR2011-002602-78-DETeva Women's Health Research&Development, a division of Teva Branded Pharmaceutical Products R&D, Inc.240
进行中（未招募）
1 期
A clinical research study to evaluate the impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women.The impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women(contraceptive)MedDRA version: 14.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-002602-78-ESTeva Women's Health Research&Development, a division of Teva Branded Pharmaceutical Products R&D, Inc.240