Clinical trial NCT00144235: Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mental Competency
Mental Fatigue
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 412
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: 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.
timeFrame: 28 days
Secondary outcomes:
measure: 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.
timeFrame: 28 days
measure: 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
timeFrame: 28 days
measure: The baseline (day 0 pre-dose) adjusted change scores at day 28 in the individual CDR tests.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: The baseline (day 0 pre-dose) adjusted change scores at day 0 in the individual CDR tests
timeFrame: 28 days
measure: 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
timeFrame: 28 days
measure: Incidence of all adverse events
timeFrame: 28 days
measure: Vital signs (BP and HR)
timeFrame: 28 days
measure: Overall tolerability assessment by the subject and investigator
timeFrame: 28 days
Other outcomes:
Locations:
city: Aldershot
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Pharmaton
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: