Status:
COMPLETED
Levo Phencynonate Hydrochloride for the Prevention of Seasickness
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Conditions:
Motion Sickness
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.
Detailed Description
The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experi...
Eligibility Criteria
Inclusion
- Subjects fulfilling the diagnostic criteria for motion sickness
- Have medical history for motion sickness
- During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.
- Adults for 18-55 years, male or female.
- Agree to participate the study and can sign the ICF independently.
Exclusion
- Be allergic to the study drug or be allergic constitution
- ALT, AST≥ 1.5 times of ULN, Scr\>ULN, or other clinical significant lab values.
- Abnormal ECG which is clinical significant judged by investigators, including: QTc\>normal range
- Have medical history for urination disorder
- Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.
- Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )
- Have internal ear disease which may disturb the evaluation of motion sickness.
- Have glaucoma or posterior circulation ischemia
- Have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study.
- Participated in other studies within the past 3 months.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02241629
Start Date
August 1 2014
End Date
February 1 2015
Last Update
May 7 2015
Active Locations (1)
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1
Qingdao municipal hospital
Qingdao, Shandong, China