EUCTR2006-002087-26-ES进行中（未招募）不适用
An open label, comparative, randomised, balanced crossover trial comparing nasal fentanyl and oral transmucosal fentanyl (Actiq) in breakthrough pain in patients with cancer
ycomed Danmark ApS0 个研究点目标入组 115 人开始时间: 2012年3月15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
- 115
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
- •All inclusion criteria must be answered yes
- •Has the patient given informed consent according to applicable requirements before any trial-related activities
- •Is the patient a cancer patient with breakthrough pain (BTP)
- •Is the patient 18 years or above
- •Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain
- •Is the current dose of the scheduled background pain opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200µg/hour
- •Is the background pain gererally stable and on average controlled to a mild level by the background pain opioid
- •Is the BTP episodes in general of so severe pain intensity that the patient judges he/she needs additional analgesics( apart from background pain medication)
- •In general does the patient have at least three BTP episodes per week but no more than four BTP episodes per day while using a stable fixed-schedule opioid regimen
- •Has the patient obtained at least partial relief of BTP with his/her usual immediate release strong opioid i.e. morphine, oxycodone, hydromorphine or transmucosal fentanyl
- •Is the life expectancy of the patient at least 3 months
- •Is the patient able to use nasal drugs
- •For female patients of child bearing potential: Does the patient use adequate contraceptive precaution in the trial period
- •Does the patient have a negative urine or blood pregnancy test
- •Local regulatory requirements will be described in Appendix 2.
- •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 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 115
排除标准
- •All exclusion criteria must be answered no
- •Does the patient have a recent history of substance abuse
- •Is the patient pregnant or nursing during the trial period
- •Has the patient neurological or psychiatric impairment that may compromise data collection
- •Has the patient severe hepatic impairment
- •Has the patient had any recent therapy which could potentially alter pain response to analgesics to a degree where the need for background pain opioid will be less than 60 mg morphine or morphine equivalents/day or less than 25µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period
- •Has the patient ever had oral/nasal surgery or facial radiotherapy ? (Tooth extraction performed more than 30 days prior to screening is allowed)
- •Has the patient received radiotherapy within the last 21 days or is the patient scheduled to receive radiotherapy within the next 8 weeks
- •Has the patient been treated with MAO inhibitor within the last 14 days
- •Has the patient been treated with Methadone within the last 32 days
- •Has the patient been treated with Buprenorphine within the last 16 days
- •Does the patient have an impaired respiratory function to an extent which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment
- •Does the patient use drugs for nasal administration
- •Does the patient have nasopharyngeal probe
- •Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients
- •Has the patient any head injury, primary brain tumour or other pathological conditions which could significantly increase the risk of increased intracranial pressure or impaired consciousness
- •Has the patient concomitant participation in any other trial with an investigational drug or device within 30 days prior to inclusion in this trial
- •Does the patient have pathological conditions of the nasal and/or oral cavity as contraindication to nasal fentanyl or Actiq
- •Was the patient included in FT-016-IM, FT-017-IM or FT-018-IM
研究者
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