Clinical Trial: Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 28 Day, Randomised, Double-blind, Placebo-controlled, Single-centre Trial to Evaluate the Efficacy and Safety of Pharmaton® PHL 00749 Film Coated Tablets (G115 40 mg, Multivitamin, Multimineral

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 Summary:

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.


Sponsor: Boehringer Ingelheim

Current Primary Outcome: 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. [ Time Frame: 28 days ]

Original Primary Outcome: 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.

Current Secondary Outcome:

  • 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. [ Time Frame: 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 [ Time Frame: 28 days ]
  • The baseline (day 0 pre-dose) adjusted change scores at day 28 in the individual CDR tests. [ Time Frame: 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. [ Time Frame: 28 days ]
  • The baseline (day 0 pre-dose) adjusted change scores at day 0 in the individual CDR tests [ Time Frame: 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 [ Time Frame: 28 days ]
  • Incidence of all adverse events [ Time Frame: 28 days ]
  • Vital signs (BP and HR) [ Time Frame: 28 days ]
  • Overall tolerability assessment by the subject and investigator [ Time Frame: 28 days ]


Original Secondary Outcome: Secondary Endpoints: 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. The baseline (day 0 pre-dose) adjusted change scores at day 28 in the CDR factors

Information By: Boehringer Ingelheim

Dates:
Date Received: September 2, 2005
Date Started: March 2005
Date Completion: July 2005
Last Updated: October 30, 2013
Last Verified: October 2013