HealthyPhase 2Tricross-BaselNCT02904109
Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
A Phase 2 study testing Triflusal in people with Healthy, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Triflusal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Sep 2016to 28 Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female
- normotensive (BP between 90/60mmHg and 140/90mmHg)
- BMI between 19 and 29 kg/m2
- aged between 18 and 40 years
- experiencing chronic stress for at least 1 month (TICS sum score in subscale "overextension at work" >= 55)
- native or fluent German-speaking
Show all 9Show fewer
- able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
- willing to donate saliva sample for DNA-analysis
- female: willing to perform a pregnancy test at the beginning of both medication phase and at the follow-up visit.
Who cannot join
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to salicylates and other NSAIDs
- acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) except symptoms of chronic stress
- cognitive impairment as detected by DemTect
- concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
- women who are pregnant or breast feeding
- intention to become pregnant during the course of the study
Show all 15Show fewer
- lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- active peptic ulcer or antecedents or complicated peptic ulcer or history of peptic ulcer. Any other active pathological bleeding
- history of coagulation abnormality
- thyroid problems
- laboratory exclusion criteria: clinically significant values of blood count (incl. platelets), coagulation status or blood chemistry outside reference range of laboratory
- pathological ECG
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- participation in another study with investigational drug within the 30 days preceding -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, Basel, 4055
About this study
Official title: Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.
Read the detailed description
Randomised, placebo controlled, double blind, cross-over design
Primary study outcome is:
Performance in a verbal memory task.
Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and subjective memory impairment.
Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 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
- Healthy
- Being tested
- Triflusal, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriflusalDrug
Also called Disgren®
Once daily oral administration of 600 mg triflusal Disgren® for 8 days.
PlaceboDrug
Also called mannitol
Once daily oral administration of placebo mannitol for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Verum/Placebo | Experimental | This group will start with triflusal and after washout will receive placebo. Receives: Drug: Triflusal; Drug: Placebo |
| Placebo/Verum | Experimental | This group will start with placebo and will receive triflusal after washout. Receives: Drug: Triflusal; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly *
Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Secondary outcomes (7)
Change in performance in working memory task between placebo and verum at two different time points.
Working memory as assessed by digit span task. Number of correctly remembered digitsis counted.
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Change in performance in episodic memory task between placebo and verum at two different time points.
Episodic memory is assessed by the visual/spatial and verbal memory test VVM (Building und roadmap) (Quiske 2000). Number of correct answers is counted
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Change in performance in a memory game between placebo and verum at two different time points.
A memory game consisting of 12 pictures will be used to assess episodic memory.Total score is calculated by summing the correctly located pictures after 3 rounds of the game
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Change in subjective memory impairment between placebo and verum
a two part questionnaire (MIQ) consisting of a 10-item Rasch modeled Memory self-efficacy scale (Zelinski and Gilewski 2004) extended by 6 items as second part.Total score is calculated by summing the answers of each part.
Measured: 20 min before last medication of each placebo and verum
Mood state changes between placebo and verum at two different time points.
Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items.
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Changes in depressive symptoms between placebo and verum at two different time points.
Depressive symptoms as assessed by self-rating instrument MADRS. Total score is calculated by summing the answers of nine items.
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Changes in anxiety symptoms between placebo and verum at two different time points.
Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers.
Measured: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start13 Sep 2016
- Primary completion21 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904109
- Sponsor's protocol ID
- 2016DR2116
- Acronym
- Tricross-Basel
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2016
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
- ClinicalTrials.gov ID
- NCT02904109
- Acronym / sponsor ID
- Tricross-Basel / 2016DR2116
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.
Detailed description
Randomised, placebo controlled, double blind, cross-over design
Primary study outcome is:
Performance in a verbal memory task.
Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and subjective memory impairment.
Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum/Placebo | Experimental | Drug: Triflusal, Drug: PlaceboThis group will start with triflusal and after washout will receive placebo. |
| Placebo/Verum | Experimental | Drug: Triflusal, Drug: PlaceboThis group will start with placebo and will receive triflusal after washout. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- male or female
- normotensive (BP between 90/60mmHg and 140/90mmHg)
- BMI between 19 and 29 kg/m2
- aged between 18 and 40 years
- experiencing chronic stress for at least 1 month (TICS sum score in subscale "overextension at work" >= 55)
Key exclusion criteria (15 listed)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to salicylates and other NSAIDs
- acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) except symptoms of chronic stress
- cognitive impairment as detected by DemTect
- concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
- women who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriflusalAlso: Disgren®Once daily oral administration of 600 mg triflusal Disgren® for 8 days. | Drug | Placebo/Verum, Verum/Placebo |
| PlaceboAlso: mannitolOnce daily oral administration of placebo mannitol for 8 days. | Drug | Placebo/Verum, Verum/Placebo |
Primary outcome
Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly *
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted.
7 secondary outcomes
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 1:45 minutes after last medication.
Change in performance in episodic memory task between placebo and verum at two different time points.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Change in performance in a memory game between placebo and verum at two different time points.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Change in subjective memory impairment between placebo and verum
Time frame: 20 min before last medication of each placebo and verum
Mood state changes between placebo and verum at two different time points.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes 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 1:45 minutes after last medication.
Changes in anxiety symptoms between placebo and verum at two different time points.
Time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triflusal in people with Healthy, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly * (time frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.