NCT00345735已完成2 期
Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients. A Randomised, Double-blind, Placebo-controlled, Cross-over Confirmatory Trial Testing Fentanyl and Placebo in Eight Breakthrough Pain Episodes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain intensity difference at 10 minutes (PID10) after administration
研究概览
简要总结
Primary Objective:
To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain (BTP) in cancer patients.
Secondary Objective:
To explore the relationship between the response to the fentanyl dose and the stable background pain opioid dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 procedures 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 pain opioid of the patient equivalent to 60-500 mg oral morphine/day or to 25-200 µg/hour transdermal fentanyl?
- •Is the background pain generally stable and on average controlled to a mild level (defined as ≤ 4 on an 11-point numerical rating scale [NRS]) by the background pain opioid?
- •Is the BTP(s) in general of such 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?
- •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 life expectancy of the patient at least 3 months?
- •Is the patient able to use intranasal drugs?
- •Does the patient use adequate contraceptive precautions (contraceptive pill, implant or injection, or intrauterine device) in the trial period?
- •Does the patient have a negative pregnancy test?
- •Was the background pain, during a minimum of five of the seven days, controlled to a mild level (defined as ≤ 4 on an 11-point NRS) by the background pain opioid?
- •Did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day?
- •Was the BTP(s) of such severe pain intensity that the patient took additional analgesics (apart from the usual background pain opioid)?
排除标准
- •Does the patient have a recent history of substance abuse?
- •Is the patient pregnant or nursing during the trial period?
- •Does the patient have neurological or psychiatric impairment that may compromise data collection?
- •Does the patient have 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 pain 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 a monoamine oxidase (MAO) inhibitor within the last 14 days?
- •Does the patient use methadone or buprenorphine?
- •Does the patient have 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 a nasopharyngeal probe?
- •Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
- •Does the patient have any head injury, primary brain tumour, or other pathological conditions which could significantly increase the risk of increased intracranial pressure or impaired consciousness?
- •Is the patient concomitantly participating in any other trial with an investigational drug or device apart from cancer treatment and participation in NAF trial FT-016-IM within 30 days prior to inclusion in this trial?
- •Does the patient have pathological conditions of the nasal cavity as contraindications to intranasal fentanyl?
结局指标
主要结局
Pain intensity difference at 10 minutes (PID10) after administration
次要结局
- Sum of pain intensity differences over the 0-60 minute time interval (SPID0-60) and General Impression (GI) with 5 point verbal rating scale at 60 minutes
研究者
研究点 (2)
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