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

• Conditions: This study will evaluate the impact of betahistine on motion sickness.; MedDRA version: 9.1Level: LLTClassification code 10027990Term: Motion sickness

• Registration Number: EUCTR2008-000885-21-NL
• Lead Sponsor: TNO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified