2024-519131-42-02招募中4 期
F-puff_SE_2024
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- responder rate (on NPRS scale)
研究概览
简要总结
Questionary to Fentanyl Nasal Spray Efficiancy and Safety
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •OVER 18 YEARS CANCER PATIENTS UNDER PAIN THERAPY
- •We consider the study to be professionally based only among patients who are treated with F-puff according to the simplified off label recommendation, under routine treatment. Please amend the inclusion criteria with the following: - Patients with severe cancer, where beyond the standard pain relief therapy, severe, acute pain (breakthrough pain) occurs, and who were diagnosed with cancer according to the simplified off label access recommendation by HU NCA (NNGYK) (case number: NNGYK/GYSZ/40594-2/2024).
- •major opioid therapy
- •clear state of mind
- •they can use the nasal spray by themselfes
- •not pregnant, not breastfeeding
- •no cancerous tumour in mouth or nose
- •breath count above 10/min
- •no known fentanyl allergy
排除标准
- •YOUNGER THAN 18 YEARS OLD
- •no malignacy
- •Week lung capacity where assisted respiration is not needed (due to the respiration depressant effect of drugs with morphymomethic nature)
- •Hypersensitivity to fentanyl or to any opioids.
结局指标
主要结局
responder rate (on NPRS scale)
responder rate (on NPRS scale)
次要结局
未报告次要终点
研究者
Horvath Bohus Anna
Scientific
Semmelweis University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Satisfaction of Fentanyl nose spray administrated to decrease pain.break through painfentanyl nose spraysatisfactiondoorbraakpijnenfentanyl neusspraytevredenheidNL-OMON28012Maastricht university medical center25
暂停
不适用
Efficacy and Safety of Intranasal Fentanyl vs Intranasal Dexmedetomidine for Preoperative Sedation in Anxious Children Undergoing Day Surgery, A Non-inferiority Double-blinded Randomized Controlled TrialPreoperative anxietyPediatricFentanylDexmedetomidineTCTR20180426002Siriraj Research Development Fund Managed by Routine to Research : R2R46
已完成
不适用
Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal MucositisBreakthrough PainMucositisRadiotherapyChemotherapyHead and Neck CancerNCT02050503Grupo de Investigación Clínica en Oncología Radioterapia33
尚未招募
不适用
Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor RhinitisVasomotor RhinitisNCT07266688Liaquat University of Medical & Health Sciences100
已完成
2 期
The effect of sublingual fentanyl pill in the treatment of sudden pain in patients with cancerBreakthrough Pain in Patients with Cancer.Neoplasm related pain (acute) (chronic)G89.3IRCT20131124015515N8Shahid Beheshti University of Medical Sciences100