A prospective, randomized, double blind, placebo controlled, parallelgroup, multicenter, clinical study to evaluate safety and efficacy ofPhlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml inprevention of infusion associated phlebitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 7
- 主要终点
- Incidence of infusion phlebitis (grade II & above) during 72 hours of
研究概览
简要总结
A prospective, randomized, double blind, placebo controlled, parallel group, multicenter, clinical study to evaluate safety and efficacy of Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml in prevention of infusion associated phlebitis.
Primary efficacy end point: Both treatments will be compared forï‚· Incidence of infusion phlebitis (grade II & above) during 72 hours of treatment period
Secondary efficacy end points: Both treatments will be compared for 1. Mean time to develop infusion phlebitis (grade II or above) in hours. For patients not reaching grade II by 72 hours, it will be 72 hours. 2. Mean maximum intensity of pain experienced by patients at IV site recorded on 100 mm Visual Analogue Scale (VAS) during 72 hours of treatment period. 3. Incidence of first signs of phlebitis (grade I) 4. Mean time to develop infusion phlebitis grade I (or above) in hours
**Safety endpoints:**ï‚· Incidence of treatment emergent (probably or certainly associated with study treatment as per WHO causality assessment) application site reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Either gender, age 18 to 65 years, both inclusive 2.Undergoing peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period 3.Willing & able to comply with study requirements, e.g. regular application of IP and efficacy-safety evaluation schedule, as indicated by written informed consent provided by the patient.
- •4.If female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study.
排除标准
- •1.Undergoing re-cannulation due to phlebitis at earlier cannulation site 2.Unconscious or comatose patients 3.History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia 4.Planned administration of any of the following during study period: ï‚· Anti-coagulants locally (at IV site or in the cannula) or systemically ï‚· NSAIDs locally at IV site 5.Patients having participated in any clinical trial within last 30 days at the time of screening 6.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
结局指标
主要结局
Incidence of infusion phlebitis (grade II & above) during 72 hours of
时间窗: [every 8±1 hours for 72 hours starting | within 1 hour of cannulation, total 10 times
treatment period
时间窗: [every 8±1 hours for 72 hours starting | within 1 hour of cannulation, total 10 times
次要结局
- 1. Mean time to develop infusion phlebitis (grade II or above) in hours.(For patients not reaching grade II by 72 hours, it will be 72 hours.)