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

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).

Study Overview

• Status: Completed
• Conditions: The Primary Condition Studied for This Trial is Acute Stress
• Intervention / Treatment: Drug: Placebo; Drug: Zeller Entspannung film coated tablet; Other: No Treatment

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Phase I Research Unit, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Max Zeller Soehne AG

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Ze 185-4-2014-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No