An Exploratory Study to Investigate Pain Related to Injection of Large Volumes (up to 5mL) Subcutaneously
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Injection pain rated on a Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Healthy male or female participants as judged by the investigator.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body Mass Index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 30.0 kilograms per square metre (kg/m^2) (both included).
- •White (Light skin that allows for adequate medical evaluation of any skin reactions).
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Previous randomisation in this study.
- •Previous rescreening for this study.
- •Pregnant or breastfeeding female participants.
- •Current participation (i.e., signed informed consent) in any other interventional clinical study. Treatment with an investigational medical product within 3 months or 5 half-lives (if known), whichever is longer prior to screening.
- •Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol, including insufficient abdominal area for injection.
- •Intake of any medication that could influence pain perception or injection site reaction appearance (e.g., anti-coagulants, including low dose of aspirin, systemic antihistamines, pain-relieving, or anti-inflammatory medicinal products) within the last week before the intervention.
- •Intake of alcohol within the last 24 hours (self-reported) or a positive result of alcohol breath test prior to randomisation and intervention.
- •Intake of illicit drugs within the last 48 hours (self-reported) or a positive result of urine drug screening prior to screening.
- •Use of any nicotine products within the past month before screening.
- •Known active or inactive skin condition or disease, tattoos, or other interventions in the injection area that may affect pain perception or assessment of injection-site reactions.
- •Strenuous exercise within 3 days prior to the intervention.
研究组 & 干预措施
Pilot cohort
Participants will receive subcutaneous injections and infusions of sodium chloride (NaCl) solution in varying combinations of speed and volume at different abdominal sites in a randomised sequence. A syringe pump with an attached syringe will be used for delivery of subcutaneous injections and infusions.
干预措施: Syringe Pump (Device)
Main cohort
Participants will receive subcutaneous injections and infusions of sodium chloride (NaCl) solution in varying combinations of speed and volume (that have passed safety assessment in pilot cohort) at different abdominal sites in a randomised sequence. A syringe pump with an attached syringe will be used for delivery of subcutaneous injections and infusions.
干预措施: Syringe Pump (Device)
结局指标
主要结局
Injection pain rated on a Visual Analogue Scale (VAS)
时间窗: 1 minute (±1 minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm).
Injection pain rated on a VAS
时间窗: 9 minutes (±1minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm.
次要结局
- Acceptance of pain for each injection (including the needle insertions only) as a binary measure(1 minute (±1 minute) from the injection initiation)
- Back flow at the injection site(5 minutes (±1 minute) from the injection initiation)
- Number of acute injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation) after each injection(9 minutes (±1 minute) from the injection initiation)
- Number of long term injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation)(16-40 hours after all injections with an additional 36 hours if a clinic visit is needed)
- Number of adverse events(Up to 40 hours after completing all the injections with an additional 36 hours if a clinic visit is needed)