Clinical Trial: Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study

Brief Summary: A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.

Detailed Summary: 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.
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Current Primary Outcome: the symptoms of seasickness [ Time Frame: Two hours of voyage ]

Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sihuan Pharmaceutical Holdings Group Ltd.

Dates:
Date Received: September 12, 2014
Date Started: August 2014
Date Completion:
Last Updated: May 6, 2015
Last Verified: September 2014