Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

Sponsor

Max Zeller Soehne AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02189239

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
The Primary Condition Studied for This Trial is Acute Stress	Drug: Zeller Entspannung film coated tablet Drug: Placebo Other: No Treatment	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Zeller Entspannung film coated tablet
Placebo Comparator: 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.	Drug: Placebo
Sham Comparator: No Treatment No medication intake.	Other: No Treatment

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Zeller Entspannung film coated tablet

Placebo Comparator: 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.

Drug: Placebo

Sham Comparator: No Treatment

No medication intake.

Other: No Treatment

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Research Unit, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

Max Zeller Soehne AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Max Zeller Soehne AG

ClinicalTrials.gov Identifier:

NCT02189239

Other Study ID Numbers:

Ze 185-4-2014-02

First Posted:

Jul 14, 2014

Last Update Posted:

Jun 25, 2015

Last Verified:

Jun 1, 2015

Study Results

No Results Posted as of Jun 25, 2015