Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Motion Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241629
• Other study ID #: BOJI-1423Q
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2014
• Last updated: May 6, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2014
• Source: Sihuan Pharmaceutical Holdings Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Motion Sickness

Intervention

Drug:
• placebo
placebo of levo phencynonate hydrochloride
• levo phencynonate hydrochloride
levo phencynonate hydrochloride

Locations

Country	Name	City	State
China	Qingdao municipal hospital	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Sihuan Pharmaceutical Holdings Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the symptoms of seasickness	Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.	Two hours of voyage	Yes