Status:
COMPLETED
A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Conditions:
Vertigo
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of ...
Detailed Description
This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days treatment and 7 days follow-up. The study includes three arms: high dose, low dose and placebo control.To observe...
Eligibility Criteria
Inclusion
- At the age more than 18 years old male or female;
- Patients with vertigo caused by Posterior Circulation Infarction.
- Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;
- Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);
- Ability to sign the statements of informed consent;
Exclusion
- Female patients having Pregnant, Lactating or Birth plan recently;
- Non-posterior circulation infarction patients;
- Vertigo caused by any other diseases;
- Long-term alcohol abuse, or drug abuse;
- Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;
- History of allergies on Levophencynonate Hydrochloric or these compositions;
- Participation in another clinical trial in three months;
- Investigator thought that should be excluded due to other reason;
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT02299804
Start Date
January 1 2014
End Date
August 1 2015
Last Update
April 15 2016
Active Locations (1)
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1
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127