Back to resultsA Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo
Primary Purpose
Vertigo
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Levophencynonate Hydrochloric
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vertigo
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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;
Sites / Locations
- Renji Hospital Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High dose arm
Low dose arm
Placebo arm
Arm Description
Have included the Levophencynonate Hydrochloric 1.5mg bid.
Have included the Levophencynonate Hydrochloric 1.0mg bid.
Have no any active component
Outcomes
Primary Outcome Measures
The duration of vertigo
The Software Statistical Analysis System (SAS) will be used to deal with 98 subjects' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaire will be resolved by investigator detailed. Hypothesis test results of effectiveness provide evidence as reference.
Secondary Outcome Measures
Vertigo severity improved（VAS score）
The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.
Nerve function improved（NIHSS/MRS score）
The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.
Full Information
NCT ID
NCT02299804
First Posted
October 9, 2014
Last Updated
April 14, 2016
Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02299804
Brief Title
A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo
Official Title
A Multicenter, Double-Blind, Phase Ⅱ Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo Caused By Posterior Circulation Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to study the safety of Levophencynonate Hydrochloric.
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 the efficacy by change of vertigo severity and duration,and safety by vital sign,adverse event,etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose arm
Arm Type
Experimental
Arm Description
Have included the Levophencynonate Hydrochloric 1.5mg bid.
Arm Title
Low dose arm
Arm Type
Experimental
Arm Description
Have included the Levophencynonate Hydrochloric 1.0mg bid.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Have no any active component
Intervention Type
Drug
Intervention Name(s)
Levophencynonate Hydrochloric
Intervention Description
this drug is M receptor inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No active ingredient
Primary Outcome Measure Information:
Title
The duration of vertigo
Description
The Software Statistical Analysis System (SAS) will be used to deal with 98 subjects' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaire will be resolved by investigator detailed. Hypothesis test results of effectiveness provide evidence as reference.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Vertigo severity improved（VAS score）
Description
The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.
Time Frame
up to 7 days
Title
Nerve function improved（NIHSS/MRS score）
Description
The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yansheng Li, PHD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo
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