Status:
COMPLETED
Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Mental Competency
Mental Fatigue
Eligibility:
All Genders
20-50 years
Phase:
PHASE3
Brief Summary
To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and allevi ating mental and physical stress in healthy male and female subjects leading demanding lifestyles.
Detailed Description
This is a double-blind, placebo-controlled, randomised, parallel group trial in healthy male and fem ale subjects in regular employment. The duration of dosing will be 28 '(+/- 1)' days and assessment...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA Healthy male and female subjects in regular employment, aged between 20 and 50 y ears. Subjects who give written informed consent in accordance with GCP and local legi slation.
- EXCLUSION CRITERIA Subjects who present with clinical depression. Subjects showing evidence of dementia. Clinically relevant abnormalities in medical history or examination. Subjects who have participated in a clinical study within 3 months prior to the start of the study. History of drug and/or alcohol abuse. Subjects who smoke more than 10 cigarettes per day. Subjects who in the opinion of the Investigator are heavy users of other tobacco or nicotine products (e.g. snuff, chewing tobacco, nicotine patches, nicotine g um, etc.). Subjects who have a history of food and/or drug allergies relevant to the study compound. Clinically relevant deviation from normal of any finding during pre-study medica l screening. Subjects who are unable to perform the cognitive tests. Subjects currently taking a cognition enhancing substance, including any Ginkgo, ginseng or guarana product. Any subject regularly taking a medication who might stop doing so at some time d uring the active dosing phase. Pregnant or lactating women or female subjects of child-bearing potential not us ing adequate means of birth control (condoms, contraceptive pills, IUDs, sterili sation). Subjects already taking other multi-vitamin products during the last 2 weeks. Healthy subjects who are regularly taking drugs which act on the Central Nervous System (CNS).
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00144235
Start Date
March 1 2005
End Date
July 1 2005
Last Update
October 31 2013
Active Locations (1)
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1
Boehringer Ingelheim Investigational Site
Aldershot, United Kingdom, GU11 3RB