Healthy volunteers trial with registered NSAID.
Conditions
Interventions
Trade Name: Indometacine PCH
Product Name: Indometacine
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Sint Maartenskliniek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age between 50-70 - not using any NSAIDs for at least 3 days prior to the first intake of the medicin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - neurological or orthopedic disorders - poor comprehension of Dutch language - hearing problems - acutely existing Ulcus ventriculi and/or duodeni, or history of Ulcus - allergy against Indomethacin, Aspirin, or other NSAIDs - patients with nasal polyps reacting with an angioedema to other NSAIDS - children under 2 years of age - severe preexisting renal and liver damage - comedication - weight >100kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the use of a NSAID like indometacin inflluences reaction time, postural balance and obstacle avoidance.;Secondary Objective: To investigate which test is most discriminative about the influence of indometacin.;Primary end point(s): Reaction time and failure rates on 3 tasks: reaction time, postural balance on force plates and obstacle avoidance on a treadmill. | — |
Countries
Netherlands
Outcome results
None listed