NCT02189239

Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Max Zeller Soehne AG · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• The Primary Condition Studied for This Trial is Acute Stress

Interventions

Type	Name	Description
DRUG	Zeller Entspannung film coated tablet
DRUG	Placebo
OTHER	No Treatment

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-07-14
• Last updated: 2015-06-25

Locations

1 site across 1 country: Switzerland