NCT00362583已完成3 期
A Double-blind, Randomised, Placebo-controlled Trial Confirming the Efficacy of Intranasal Fentanyl Titrated to 50, 100 or 200 µg With an Open Long-term Safety Follow-up in Cancer Patients With Breakthrough Pain
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
Primary objectives:
- To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for treatment of breakthrough pain (BTP) in cancer patients
- To establish long-term safety of treatment with intranasal fentanyl
Secondary objectives:
- To explore the relationship between dose of background opioid treatment and titrated fentanyl dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Is the patient a cancer patient with breakthrough pain?
- •Is the patient aged ≥18 years?
- •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 opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200 µg/hour? For conversion table.
- •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 opioid?
- •Is the BTP(s) in general of so severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain analgesics) and does it normally last for more than 15 minutes?
- •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?*
- •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?
- •Is the patient able to use intranasal drugs?
- •Does the patient use adequate contraceptive precaution (contraceptive pill, implant or injection or intrauterine device) in the trial period?
- •Did the patient have a negative pregnancy test at the inclusion in studies FT-016-IM or FT-017-IM?
排除标准
- •All exclusion criteria must be answered "no" for a patient to participate in the trial.
- •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? (Investigator's judgement according to local practice)
- •Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background opioid will be less than 60 mg morphine or morphine equivalents/day or less than 25 µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period?
- •Has the patient had facial radiotherapy?
- •Has the patient been treated with MAO inhibitor within the last 14 days?
- •Does the patient use Methadone or Buprenorphine?
- •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 intranasal 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 apart from cancer treatment and participation in intranasal fentanyl trials FT-016-IM/ FT-017-IM within 30 days prior to inclusion in this trial?
- •Does the patient have pathological conditions of the nasal cavity as contraindication to intranasal fentanyl?
研究者
研究点 (2)
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