This study will evaluate the impact of betahistine on motion sickness. MedDRA version: 9.1 Level: LLT Classification code 10027990 Term: Motion sickness
Conditions
Interventions
Trade Name: Betaserc
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
TNO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-30 years at Day 01 of the study Female volunteers should take oral contraceptives (combined or progestogen only). This is to attenuate hormonal influences on the susceptibility to motion sickness. The menstrual cycle has been shown to influence motion sickness susceptibility (Golding et al. 2004). Body Mass Index (BMI) 18-28 kg/m2 Healthy as assessed by health questionnaire (Pbetahistine F02; in Dutch) and a physical examination limited to auscultation of heart and lung, blood pressure and heart rate Susceptibility to motion sickness is more than 35 on Golding’s MSSQ scale. Participation on a voluntary basis Having given their written informed consent Willing to comply with the study procedures (e.g. the possible provocation of motion sickness) Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study Having a history of medical or surgical events that may significantly affect the study outcome as vestibular, cardiovascular, pulmonary, gastrointestinal, neurological, psychiatric, hepatic, renal, hematological or other organic abnormality or pathology, including: asthma, ulcus pepticum urticaria, or allergic complaints as a rash or allergic rhinitis). Prescribed medication that may interfere with the study outcome Inclination to hyperventilation (Nijmegen questionnaire score > 23) Not able to undergo the familiarization tests inside the moving base-simulator Desdemona (see below) Alcohol consumption females > 21 or units/week; males >28 units/week Pregnancy or breastfeeding TNO personnel and their close relatives Not having a general practitioner Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of betahistine on the severity / intensity of motion sickness ;Secondary Objective: ;Primary end point(s): It is expected that betahistine will diminish motion sickness. In both conditions of the experiment subjects will be exposed to the same motion stimulus. This stimulus will last for half an hour, or less if a certain motion sickness level (‘’moderate nausea’’), indicated by the subject, is reached prior to the end of the 30 min period. The exposure duration is the main study parameter. The tests at the intake have a dual goal: to determine the participants’ motion sickness susceptibility level, and to determine which motion stimulus is provocative enough to induce motion sickness within 30 minutes, but not within a few minutes. For this test, a motion sickness inducing stimulus will be chosen that does not invoke hyperventilation. To this effect the breathing of the subjects is analysed during the tests so that hyperventilation can be excluded. | — |
Countries
Netherlands
Outcome results
None listed