The effect of betahistine 48 mg three times daily on motion sickness

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

Female volunteers should take oral contraceptives (combined or progestogen only). 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.

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
Clinically relevant medical problems (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).
Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study
Subjects who are mentally handicapped.
Subjects who have taken (non)prescription medications within the last 14 days, with the exception of painkillers such as aspirin, paracetamol, ibuprofen, up to 72 hours prior to the start of the study.
Inclination to hyperventilation (Nijmegen questionnaire score > 23)
Not able to undergo the familiarization tests inside the moving base-simulator Desdemona
Alcohol consumption females > 21 or units/week; males >28 units/week
Pregnancy or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>It is expected that betahistine will diminish motion sickness. In both<br /><br>conditions of the experiment subjects will be exposed to the same motion<br /><br>stimulus. This stimulus will last for half an hour, or less if a certain motion<br /><br>sickness level (moderate nausea), indicated by the subject, is reached<br /><br>prior to the end of the 30 min period. The exposure duration is the main study<br /><br>parameter.<br /><br>The tests at the screening have a dual goal: to determine the<br /><br>participants*motion sickness susceptibility level, and to determine which<br /><br>motion stimulus is provocative enough to induce motion sickness within 30<br /><br>minutes, but not within a few minutes. For this test, a motion sickness<br /><br>inducing stimulus will be chosen that does not invoke hyperventilation. To this<br /><br>effect the breathing of the subjects is analysed during the tests so that<br /><br>hyperventilation can be excluded.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>

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