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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
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).
Details
| Lead sponsor | Max Zeller Soehne AG |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 72 |
| Start date | 2015-01 |
| Completion | 2015-06 |
Conditions
- The Primary Condition Studied for This Trial is Acute Stress
Interventions
- Zeller Entspannung film coated tablet
- Placebo
- No Treatment
Primary outcomes
- 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. — 4 days
Countries
Switzerland