Pain Induced by m-Cresol as Preservative - A Randomised Controlled Crossover-Trial in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
研究概览
简要总结
Preservatives such as m-Cresol are essential components in many subcutaneously injected medications, including insulin or human growth hormone, to prevent bacterial growth. However, clinical reports have suggested that these preservatives may cause local discomfort or pain at the injection site, which can negatively impact treatment adherence. While m-Cresol is widely used, its direct contribution to injection-site pain has not yet been investigated in a prospective clinical trial.
This study aims to investigate whether subcutaneous injection of m-Cresol at concentrations commonly used in clinical practice (0.1% and 0.25%) cause significantly more pain than a preservative-free control solution. In a randomized, double-blind crossover design, healthy volunteers will receive three separate injections in a belly fold. Participants will rate their pain every 5 seconds until it subsides. The findings will help determine if m-Cresol is a primary source of injection-site pain and could lead to the development of more comfortable drug formulations.
详细描述
Background and Objective:
m-Cresol has been used since 1980 to limit bacterial growth in parenteral medications. Although it is generally considered safe, evidence for local side effects has appeared in case reports and a clinical trial where changing the preservative led to a disappearance of local discomfort. This suggests that the preservative itself, rather than the active drug or the pH of the solution, may be responsible for a pain sensation. The objective of this study is to systematically evaluate if subcutaneous injection of m-Cresol at clinically relevant concentrations causes pain in humans.
Study Design:
This is a randomized, double-blind, placebo-controlled, 3-period crossover trial in healthy volunteers (n=18). To ensure an unbiased assessment and control for potential order effects, a Williams balanced design is utilized for the randomization of treatment sequences.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years
- •Full legal capacity
排除标准
- •Participant of another study, ongoing or within the last four weeks
- •Current medication intake (except hormonal contraception) or drug abuse
- •Female subjects: Positive pregnancy test or breastfeeding
- •Body temperature above 38°C, verified by infrared thermometer
- •Known allergic diseases, in particular asthmatic disorders and skin diseases
- •Sensory deficit, skin disease or hematoma of unknown origin in the examination of the test site
研究者
Stefan Heber
Principal Investigator
Medical University of Vienna