Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

NCT02189239 | Completed Phase 4

• 1 other identifier: Ze 185-4-2014-02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

The Primary Condition Studied for This Trial is Acute Stress

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Zeller Entspannung film coated tablets

ACTIVE COMPARATOR

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 tablets

PLACEBO COMPARATOR

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

No Treatment

SHAM COMPARATOR

No medication intake.

Other: No Treatment

Interventions

Zeller Entspannung film coated tablet DRUG

Zeller Entspannung film coated tablets

Placebo DRUG

Placebo tablets

No Treatment OTHER

No Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age:18 - 45 years
• Written informed consent
• Male gender

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Max Zeller Soehne AG: lead

Study Sites (1)

Phase I Research Unit, University Hospital Basel

Basel, 4031, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

CH (1)