CTRI/2009/091/000243未知3 期
A multicentre, multinational, randomizedm Double-Blind, Placebo Controlled, crossover trial to evaluate efficacy and safety of Fentanyl TAIFUN ® treatment after titrated dose administration for breakthrough pain in cancer patients on maintenance opioid therapy
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 7
- 主要终点
- Efficacy parameters ( numerical Pain Scale )
研究概览
简要总结
A multicentre, multinational, randomizedm Double-Blind, Placebo Controlled, crossover trial to evaluate efficacy and safety of Fentanyl TAIFUN ® treatment after titrated dose administration for breakthrough pain in cancer patients on maintenance opioid therapyStudy plans to enroll 180 patients and randomize 135 patients to cross over observation period so as to get 120 patients to complete the study.Of the 9 BTP episodes to be evaluated in Double Blind Observation period 6 episodes will be evaluated with IP and 3 Episodes will be evaluated withPlacebo. The Randomization will be done in blocks of 3 episodes in such a way that patient does not receive placebo twice in a row. Efficacy will be evaluted based on NPS score.
研究设计
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •"Inclusion Criteria :
- •Age 18 years or over.
- •A medically documented diagnosis of cancer.
- •Use of a fixed around-the-clock dose of an opioid or a fixed combination of opioids as maintenance therapy for pain relief with a dose equivalent of at least 60 mg of oral morphine/day, or at least 25 µg of transdermal fentanyl/hour, or at least 30 mg of oxycodone daily or at least 8 mg of oral hydromorphone daily.
- •Current opioid treatment for at least 7 days prior to the randomization.
- •Current use of opioid medication for BTP.
- •At least one BTP episode per Day with peak intensity of at least 4 on the numerical pain scale (NPS) at pain onset.
- •No more than 4 BTP episodes per day.
- •BTP is defined as a transitory increase in pain to greater than moderate intensity which occurs on a baseline pain of moderate intensity or less.
- •The flow rate of inhalation of at least 20 L/min assessed by inspiratory flow meter (the highest of two readings will be used).
- •Written informed consent.
排除标准
- •"Exclusion Criteria:
- •Uncontrolled or rapidly increasing BTP
- •Symptomatic intracranial tumors or cerebral metastases.
- •Persistent, symptomatic asthma despite medication, as defined by daily symptoms, frequent exacerbations, frequent nocturnal asthma symptoms, predicted FEV1 <60% or personal best PEFR < 60%.
- •Patients unable to use the inhaler (Based on Investigator?s opinion)
- •Inadequate lung function, as defined by PEFR < 60 %
- •Hypersensitivities, allergies or contraindications to fentanyl or study medication components
- •Radiotherapy to the thorax within 30 days of the beginning of the titration phase.
- •Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the patient to complete the assessments.
- •Participation in any clinical study with experimental drug within 30 days of the randomization, except participation in prior Fentanyl TAIFUN® studies.
- •11.Any clinical condition [e.g. severe hepatic impairment defined by: (1) serum total bilirubin higher than 3 x upper limit of normal (ULN) and/or, (2) serum alanine aminotransferase and serum aspartate aminotransferase higher than 10 x ULN, (3) serum albumin lower than 28 g/L in conjunction with either (1) or (2)], or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of maintenance opioid therapy).
- •Pre-menopausal women (last menstruation < 1 year prior to the screening visit) who:?
- •are not surgically sterile and/or?
- •have a positive pregnancy test at baseline visit and/or?
- •are of childbearing potential and are not practicing an acceptable means of birth control or do not plan to continue using this method throughout the study and/or are nursing.
结局指标
主要结局
Efficacy parameters ( numerical Pain Scale )
时间窗: T = 15minutes , T = 60minutes
次要结局
- Safety parameters ( Vital Signs, Pulse oxymeter, Spirometry, ECG, PEFR, PIFR, Laboratory Parameters )(4 Hours in titration period immediately after drug administration. The patient will be monitored for safety parameters for 28 days)
研究者
研究点 (7)
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