EUCTR2005-002347-82-DK进行中（未招募）不适用
Intranasal fentanyl for the treatment of breakthrough pain in cancer patients: A randomised, double-blind, placebo-controlled, cross-over confirmatory trial testing the doses 50, 100 and 200 µg fentanyl and placebo in eight break-through pain episodes
ycomed Danmark ApS0 个研究点目标入组 175 人开始时间: 2006年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
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” for a patient to participate in the trial.
- •Inclusion criteria at screening
- •1. Has the patient given informed consent according to local requirements before any trial-related activities? Trial-related activities are any procedure that would not have been performed during the routine management of the patient
- •2. Is the patient a cancer patient with breakthrough pain?
- •3. Is the patient aged = 18 years?
- •4. Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain?
- •5. 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 25-200 µg/hour?
- •6. Is the background pain generally stable and on average controlled to a mild level (defined as = 4 on an 11 point NRS) by the background pain opioid?*
- •7. Is the BTP(s) in general of so severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain medication) and does it normally last for more than 15 minutes?
- •8. Does the patient in general while using a stable, fixed-schedule, opioid regimen have at least three BTP episodes per week but no more than four BTP episodes per day?*
- •9. Has the patient obtained at least partial relief of BTP(s) with his/her usual immediate-release strong opioid, i.e. oral morphine, oxycodone, hydromorphone or transmucosal fentanyl?
- •10. Is the life expectancy of the patient at least 3 months?
- •11. Is the patient able to use intranasal drugs?
- •* If background pain and/or number of BTP episodes are too high, please continue screening after adjustment of background pain medication.
- •For female patients of childbearing potential (Childbearing potential is considered until menopause has lasted more than 12 months. Surgically hysterectomised and surgically successfully sterilised females may be included on the same conditions as male patients).
- •12. Does the patient use adequate contraceptive precaution (contraceptive pill, implant or injection or intrauterine device) in the trial period?
- •13. Does the patient have a negative pregnancy test?
- •Additional inclusion criteria evaluated before the 200 µg NAF test dose at baseline-visit:
- •The inclusion criteria 14-16 must apply based on the diary recordings by the patient performed during seven days between screening and baseline visit. Adjustment of background pain opioid followed by diary recording must continue until inclusion criteria 14-16 apply.
- •14. Was the background pain during minimum five of the seven days controlled to a mild level (defined as = 4 on an 11-point NRS) by the background pain opioid?
- •15. Did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day?
- •16. Was the BTP(s) of such severe pain intensity that the patient took additional analgesics (apart from the usual background pain opioid)?
- •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
- •All exclusion criteria must be answered no” for a patient to participate in the trial.
- •Exclusion criteria at screening
- •1. Does the patient have a recent history of substance abuse?
- •2. Is the patient pregnant or nursing during the trial period?
- •3. Has the patient neurological or psychiatric impairment sufficient to compromise data collection?
- •4. Has the patient severe hepatic impairment? (Investigator’s judgement according to local practice)
- •5. Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background pain opioid will be
- •a) less than 60 mg morphine or morphine equivalents/day or
- •b) 25 µg/hour transdermal fentanyl
- •or the number of BTP episodes will be less than three per week during the trial period?
- •6. Has the patient had facial radiotherapy?
- •7. Has the patient been treated with MAO inhibitor within the last 14 days?
- •8. Does the patient use Methadone or Buprenorphine?
- •9. 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?
- •10. Does the patient use drugs for intranasal administration?
- •11. Does the patient have nasopharyngeal probe?
- •12. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of the excipients in the opioids?
- •13. 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?
- •14. Has the patient concomitant participation in any other trial with an investigational drug or device apart from curative cancer treatment and participation in NAF trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial?
- •15. Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl?
研究者
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