Influence of Triflusal on Cognitive Functions in Healthy Subjects (Tribunal-Basel)

November 9, 2015 updated by: Prof. Dominique de Quervain, MD

Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Healthy Participants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4055
        • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Laboratory exclusion criteria: values of blood count, blood chemistry and coagulation status outside normal range
  • Pathological ECG
  • Pregnancy, breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Placebo/Verum
This group will start with placebo and will receive triflusal after washout.
Drug: Triflusal
Once daily oral administration of 600 mg triflusal Disgren® for 7 days.
Other Names:
  • Disgren®
Drug: Placebo
Once daily oral administration of placebo mannitol for 7 days
Other Names:
  • Mannitol
Experimental: Verum/Placebo
This group will start with triflusal and after washout will receive placebo
Drug: Triflusal
Once daily oral administration of 600 mg triflusal Disgren® for 7 days.
Other Names:
  • Disgren®
Drug: Placebo
Once daily oral administration of placebo mannitol for 7 days
Other Names:
  • Mannitol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Picture task as described in (de Quervain, Kolassa et al. 2007). Number of correctly remembered pictures is counted.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in performance in working memory task between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Working memory as assessed by digit span task. Number of correctly remembered digitsis counted.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Change in performance in a cognitive task between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Cognitive performance as assessed by BOMAT matrix reasoning task. Number of correct solutions is counted.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Mood state changes between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Changes in depressive symptoms between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Depressive symptoms as assessed by self-rating instrument MADRS.Total score is calculated by summing the answers of nine items.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Change in anxiety symptoms between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Change in motivation between placebo and verum at two different time points.
Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.
Motivation is assessed by a visual analogue scale ranging between 0 and 10.
Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dominique de Quervain, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominique De Quervain, MD, Division of Cognitive Neuroscience University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014DR2154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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