Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144235
First received: September 2, 2005
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Mental Competency
Mental Fatigue
Drug: Pharmaton PHL 00749
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 + Guarana 75 mg) 1/Day p.o. in Improving Mental Performance and to Decrease Fatigue in Healthy Male and Female Subjects in Regular Employment.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The baseline (day 0 pre-dose) adjusted change scores at day 28 in the individual CDR tests. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The baseline (day 0 pre-dose) adjusted change scores at day 0 in the individual CDR tests [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of all adverse events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Vital signs (BP and HR) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Overall tolerability assessment by the subject and investigator [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 412
Study Start Date: March 2005
Estimated Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144235

Locations
United Kingdom
Boehringer Ingelheim Investigational Site
Aldershot, United Kingdom, GU11 3RB
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Pharmaton
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00144235     History of Changes
Other Study ID Numbers: 1232.1
Study First Received: September 2, 2005
Last Updated: October 30, 2013
Health Authority: Switzerland: Blackwater Valley and Hart Primary Care Trust

Additional relevant MeSH terms:
Fatigue
Mental Fatigue
Signs and Symptoms
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 22, 2014