The Primary Condition Studied for This Trial is Acute Stress Clinical Trial
Official title:
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
| Verified date | June 2015 |
| Source | Max Zeller Soehne AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Age:18 - 45 years - Written informed consent - Male gender Exclusion Criteria: - Any acute or chronic somatic or psychiatric disorder - Smoking - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Phase I Research Unit, University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| Max Zeller Soehne AG |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |