Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue

Phase 3

Completed

• Conditions: Mental Competency; Mental Fatigue

• Registration Number: NCT00144235
• Lead Sponsor: Boehringer Ingelheim

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 assessments w ill be made on two visits (visits 2 and 3) with a training on the CDR system at the screening visit.

The subjects will receive one bottle with 35 tablets \[of either Ginseng G115 40 mg, multivitamin, mu ltimineral '+' Paullinia cupana extract PC102 75 mg (Guarana) or placebo\] from the pharmacy at the in vestigational site. The subjects should take the study drug from day 0 to day 28 '(+/- 1)' Subjects will be assigned to one of the two treatment groups randomly. The allocation ratio is 2:1..

Study Hypothesis:

H0: No difference exists between the treatment and the placebo groups in terms o f baseline-adjusted change in Power of Attention after 28 days and averaged over 4 and 6 hour time point. H1: A difference exists between the treatment and the placebo groups in terms of baseline-adjusted change in Power of Attention after 28 days and averaged over 4 and 6 hour time point. The null and alternative hypotheses for the secondary endpoints are set up accor dingly. The statistical testing will be carried out at the 0.05 level of signifi cance. The test will be performed two-tailed.

Comparison(s):

The comparator is a matching placebo film-coated tablet without active ingredien ts.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: The baseline (day 0 pre-dose) adjusted change in the CDR Factor, Power of Attention, at day 28 averaged over the 4 and 6 hour post-dosing time points.	28 days

Secondary Outcome Measures

Name	Time	Method
The baseline (day 0 pre dose) adjusted change in the CDR Factor, Power of Attention, at day 0 averaged over the 4 and 6 hour post dosing time points.	28 days
The baseline (day 0 pre-dose) adjusted change scores at day 28 in the individual CDR tests.	28 days
The day 0 pre-dose adjusted change scores at day 28 in the CDR factors: DailyStressInventory,Pro- and RetrospectiveMemoryQuest,CognitiveFailures quest, St. Mary's HospitalSleep Quest,SpielbergerStateTraitAnxiety Quest,PsychologicalGeneralWell-Being Quest	28 days
Incidence of all adverse events	28 days
Vital signs (BP and HR)	28 days
The baseline (day 0 pre-dose) adjusted change scores at day 0 in the CDR factors: Continuity of Attention, Quality of Episodic Secondary Memory, Speed of Memory and Quality of Working Memory.	28 days
The baseline (day 0 pre-dose) adjusted change scores at day 28 in the CDR factors: Continuity of Attention, Quality of Episodic Secondary Memory, Speed of Memory and Quality of Working Memory	28 days
The baseline (day 0 pre-dose) adjusted change scores at day 0 in the individual CDR tests	28 days
Overall tolerability assessment by the subject and investigator	28 days

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇬🇧 Aldershot, United Kingdom