A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo

NCT ID: NCT02299804

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High dose arm

Have included the Levophencynonate Hydrochloric 1.5mg bid.

Group Type: EXPERIMENTAL

Levophencynonate Hydrochloric

Intervention Type: DRUG

this drug is M receptor inhibitor

Low dose arm

Have included the Levophencynonate Hydrochloric 1.0mg bid.

Group Type: EXPERIMENTAL

Levophencynonate Hydrochloric

Intervention Type: DRUG

this drug is M receptor inhibitor

Placebo arm

Have no any active component

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

No active ingredient

Interventions

Levophencynonate Hydrochloric

this drug is M receptor inhibitor

Intervention Type: DRUG

Placebo

No active ingredient

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. At the age more than 18 years old male or female;

2. Patients with vertigo caused by Posterior Circulation Infarction.

3. Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;

4. Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);

5. Ability to sign the statements of informed consent;

Exclusion Criteria

1. Female patients having Pregnant, Lactating or Birth plan recently;

2. Non-posterior circulation infarction patients;

3. Vertigo caused by any other diseases;

4. Long-term alcohol abuse, or drug abuse;

5. Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;

6. History of allergies on Levophencynonate Hydrochloric or these compositions;

7. Participation in another clinical trial in three months;

8. Investigator thought that should be excluded due to other reason;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yansheng Li, PHD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LEVO-PCIV-2001

Identifier Type: -

Identifier Source: org_study_id