Influence of Triflusal on Cognitive Functions in Healthy Subjects

NCT ID: NCT02321852

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

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The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in healthy participants.

Detailed Description

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Randomised, placebo controlled, double blind, cross-over design

Primary study outcomes are:

Performance in picturial and verbal memory tasks.

Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and motivation.

Once daily oral administration of placebo mannitol for 7 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Verum/Placebo

This group will start with triflusal and after washout will receive placebo

Group Type EXPERIMENTAL

Triflusal

Intervention Type DRUG

Once daily oral administration of 600 mg triflusal Disgren® for 7 days.

Placebo

Intervention Type DRUG

Once daily oral administration of placebo mannitol for 7 days

Placebo/Verum

This group will start with placebo and will receive triflusal after washout.

Group Type EXPERIMENTAL

Triflusal

Intervention Type DRUG

Once daily oral administration of 600 mg triflusal Disgren® for 7 days.

Placebo

Intervention Type DRUG

Once daily oral administration of placebo mannitol for 7 days

Interventions

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Triflusal

Once daily oral administration of 600 mg triflusal Disgren® for 7 days.

Intervention Type DRUG

Placebo

Once daily oral administration of placebo mannitol for 7 days

Intervention Type DRUG

Other Intervention Names

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Disgren® Mannitol

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Male or female
* Normotensive
* BMI between 20 and 27 kg/m2
* Aged between 18 and 40 years
* Native or fluent German-speaking
* Caucasian
* Female practicing safe contraception

Exclusion Criteria

* Acute or chronic psychiatric or somatic disorder
* Any contraindication against aspirin or other NSAIDS
* History of coagulation disease
* History of gastrointestinal disease
* Pathological ECG
* Pregnancy, breast-feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dominique de Quervain, MD

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dominique de Quervain, MD

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dominique De Quervain, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cognitive Neuroscience University of Basel

Locations

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University of Basel, Division of Cognitive Neuroscience

Basel, Basel, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2014DR2154

Identifier Type: -

Identifier Source: org_study_id

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