EUCTR2006-006579-19-LT进行中（未招募）不适用
A double-blind, randomized, 2-way cross-over, phase II, efficacy trial in cancer patients to assess the overall efficacy, patient preference, morphine related side effect profile and safety of the Egalet® controlled release morphine formulation 30-240 mg once daily compared to MST Continus® 15-120 mg twice daily after 2 weeks of treatment
Egalet a/s0 个研究点目标入组 60 人开始时间: 2007年1月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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. The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase.
- •2. The patient has opioid-sensitive pain caused by active cancer.
- •3. The patient is aged minimum 18 years.
- •4. The patient has the ability to comprehend and communicate effectively with the Investigator and staff.
- •5. The patient has provided written informed consent.
- •6. The patient has the ability to comply with all trial requirements.
- •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. The patient has a life expectancy less than 2 months.
- •2. The patient has received chemotherapy less than 4 weeks prior to entering run-in phase
- •3. The patient has received radiation therapy less than 4 weeks prior to entering run-in phase
- •4. The patient plans to undergo radiation or chemotherapy or other non-pharmacological treatments with potential analgesic effect during the study.
- •5. Patients with medical conditions contraindicating morphine treatment: known hypersensitivity to morphine or any other component of the study drug, severe broncial asthma or obstructive airway disease, respiratory depression, increased intracranial pressure, paralytic ileus or gastrointestinal obstruction.
- •6. The patient has untreated psychiatric disease.
- •7. The patient has hepatic disease defined as a Child-Pugh score > 9 (i.e., Class C).
- •8. The patient has impaired kidney function (creatinine clearance less than 60 mL/min reported by the central laboratory).
- •9. The patient has a hematocrit less than 0.30.
- •10. The patient has a condition severely affecting gastrointestinal absorption.
- •11. The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline.
- •12. The patient is taking other opiod agonists or antagonists, zidovudine or cimetidine.
- •13. Patients taking benzodiazepines, barbiturates, phenothiazines, chloralhydrat or tricyclic antidepressants can only be included if the dose has been stable for 2 weeks pritor to the randomization visit and if the dose is expected to remain stable throughout the study.
- •14. The patient has a current alcohol or drug abuse or a history of alcohol or drug abuse within the past 24 months.
- •15. Pregnant or lactating women. Female subjects of childbearing potential must use an adequate form of contraception (i.e., oral contraceptive pill, hormonal implant, IUD or double barrier method) and have a negative urine pregnancy test at screening.
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, two way cross-over, proof of concept study to compare the efficacy, safety, pharmacokinetics and pharmacodynamics of two-week oral administration of QAV680 versus placebo, with an extended open-label inhaled corticosteroid period, in steroid-free, mild to moderate persistent asthma patientsEUCTR2008-005168-15-DEovartis Pharma Services AG50
已完成
2 期
Safety , Pharmacokinetics and efficacy of QAV680 in asthma patientsCTRI/2009/091/000282ovartis Healthcare Pvt Ltd50
招募中
不适用
A randomized, double-blind, two-way cross-over study to determine the effects of levetiracetam on corticospinal excitability in patients with treatment-controlled epilepsy, as measured by single and paired pulse TMS-EMG and TMS-EEG10039911EpilepsyNL-OMON49353Centre for Human Drug Research32
已完成
不适用
A randomized, double blind, two-way crossover clinical trial to evaluate of pharmacokinetic profiles of lacosamide in Korean subjectsKCT0003959Dong-A University Hospital48
进行中（未招募）
不适用
A controlled, randomized, double-blind, cross-over study of the onset of analgesic effect of two formulations of ibuprofen for the treatment of pain after oral surgery.PainMedDRA version: 12.0Level: LLTClassification code 10033371Term: PainEUCTR2009-015589-74-SEycomed Sweden Holding 2 AB140