Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
2017年1月18日 更新者：Novo Nordisk A/S
This trial is conducted in Europe.
The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.
研究概览
研究类型
介入性
注册 (实际的)
82
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Neuss、德国、41460
- Novo Nordisk Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 74年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Informed consent obtained before any trial-related activities.
- Type 1 or type 2 diabetes
- Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months
- Body mass index (BMI) between 18.5 and 30.0 kg/m^2 (both included)
- Caucasians
Exclusion Criteria:
- Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
- Previous participation in this trial. Participation is defined as: screened
- Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
- Injection of more than 40 units of insulin per injection
- Continuous Subcutaneous Insulin Infusion use within the last 6 months
- Continuous Glucose Monitoring use within the last 6 months
- Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
- Known active or in-active skin disease in the injection area or that may affect pain perception
- Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：Different injection speed and volume combinations
The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods.
The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject.
A subject not completing all treatments will be replaced by another subject using the same treatment arm.
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Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs.
Out of the 19 injections, 2 are needle insertions only.
The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection.
The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).
Solution for injection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Injection Pain (VAS mm)
大体时间：1 minute (±30 sec) after each injection
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Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain.
After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).
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1 minute (±30 sec) after each injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acceptance of Injection Pain After Injection of Different Volumes.
大体时间：1 minute (±30 seconds) after each injection
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Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
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1 minute (±30 seconds) after each injection
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Acceptance of Injection Pain After Injection at Different Speeds.
大体时间：1 minute (±30 sec) after each injection
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Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
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1 minute (±30 sec) after each injection
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Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.
大体时间：1 minute (±30 seconds) after each injection
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Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
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1 minute (±30 seconds) after each injection
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Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
大体时间：2 minutes (±30sec) after each injection
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Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed.
The size of the wet spot on the filter paper served as a measure of the backflow.
The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
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2 minutes (±30sec) after each injection
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Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
大体时间：2 minutes (±30sec) after each injection
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Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed.
The size of the wet spot on the filter paper served as a measure of the backflow.
The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
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2 minutes (±30sec) after each injection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2012年8月31日
首先提交符合 QC 标准的
2012年9月6日
首次发布 (估计)
2012年9月7日
研究记录更新
最后更新发布 (实际的)
2017年3月3日
上次提交的符合 QC 标准的更新
2017年1月18日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
19 injections的临床试验
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Medical College of WisconsinChildren's Hospital and Health System Foundation, Wisconsin招聘中急性淋巴细胞白血病 | 急性淋巴细胞白血病，儿科 | 急性淋巴细胞白血病，复发 | 急性淋巴细胞白血病复发 | 缓解失败的急性淋巴细胞白血病 | 急性淋巴细胞白血病未达到缓解美国
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Medical College of WisconsinChildren's Hospital and Health System Foundation, Wisconsin完全的
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University of PennsylvaniaPublic Health Management Corporation完全的
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Raphael SerreauAssistance Publique - Hôpitaux de Paris; University Hospital, Paris; François Rabelais University完全的
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University of PennsylvaniaPublic Health Management Corporation完全的
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Sara V. LatorreInstituto de Salud Carlos III; Institut d'Investigacions Biomèdiques August Pi i Sunyer主动，不招人
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Hospital Moinhos de VentoPfizer; Universidade Federal do Paraná; Inova Medical完全的
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Kanuni Sultan Suleyman Training and Research HospitalAyşegül Bestel; İbrahim Polat; Merve Aldıkaçtıoğlu Talmaç完全的