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A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseâ…¡clinical superiority study.
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 experience. 3) On-boat drug testing period. The subjects will be administered the drug before voyage. The seasickness symptoms will be evaluated during voyage. The safety test will be conducted before and after one day of on-boat testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levo phencynonate hydrochloride 1mg | Experimental | levo phencynonate hydrochloride tablet 1mg |
|
| placebo | Placebo Comparator | Placebo |
|
| levo phencynonate hydrochloride 2mg | Experimental | levo phencynonate hydrochloride 2mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo of levo phencynonate hydrochloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| the symptoms of seasickness | Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale. | Two hours of voyage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiguo Xue | Qingdao Municipal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao municipal hospital | Qingdao | Shandong | China |
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| ID | Term |
|---|---|
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| levo phencynonate hydrochloride | Drug | levo phencynonate hydrochloride |
|