A Phase IV, Randomised, Placebo Controlled Study to Investigate the Effects of Zeller Entspannung Film Coated Tablets on Cortisol Responses in Healthy Volunteers With Acute Stress
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The primary objective is to demonstrate in healthy male volunteers that Zeller Entspannung reduces overall saliva cortisol level (AUCg) after acute stress compared with a placebo.
研究概览
简要总结
The objective of the STRESS trial is to investigate in a mode of action setting the effect of Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller Entspannung will be obtained.
A third arm including no treatment is tested as well. Approximately 72 healthy volunteers will be included into this randomized, double blind study. Study duration will be 7 days, study medication intake will be over 4 days: participants will take the medication one tablet three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two tablets will be taken (morning and midday).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age:18 - 45 years
- •Written informed consent
- •Male gender
排除标准
- •Any acute or chronic somatic or psychiatric disorder
- •Any clinically relevant hepatic disorder
- •Any clinically relevant renal disorder
- •Any clinically relevant cardiac disorder
- •Any clinically relevant respiratory disease (e.g. Asthma)
- •Diabetes mellitus
- •Any abnormal lab values suggesting diseases from exclusion criteria
- •Known allergies to trial medication and excipients
- •Alcohol or other drug abuse (e.g. cannabis)
- •Concomitant participation in another clinical trial or <4 weeks ago
- •Participation in any psychotherapy
- •Already participated in a TSST
研究组 & 干预措施
Zeller Entspannung film coated tablets
Relaxing film coated tablets, 570 mg (Zeller Entspannung Filmtabletten), 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) preferably during meals with a glass of water.
干预措施: Zeller Entspannung film coated tablet (Drug)
Placebo tablets
Placebo medication is identical in presentation, color and shape, 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) during meals with a glass of water.
干预措施: Placebo (Drug)
No Treatment
No medication intake.
干预措施: No Treatment (Other)
结局指标
主要结局
The primary objective is to demonstrate in healthy male volunteers that Zeller Entspannung reduces overall saliva cortisol level (AUCg) after acute stress compared with a placebo.
时间窗: 4 days
次要结局
未报告次要终点