Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

NCT01895400 | Terminated Phase 3

• 2 other identifiers: AMC-2013-016520130055275
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.

Conditions

Recurrent Vestibulopathy

Keywords

Renexin for Recurrent Vestibulopathy

Outcome Measures

Primary Outcomes (1)

• equilibrium score of dynamic posturography

  compared with pretreatment equilibrium score

  after 8 weeks of treatment

Secondary Outcomes (3)

• dizziness handicap inventory

  at 4 weeks, 8 weeks after treatment

• visual analogue scale (VAS) of vertigo

  at 4 weeks, 8 weeks after treatment

• Questionnaire for Quality of life (SF36)

  at 4 weeks, 8 weeks after treatment

Study Arms (2)

Renexin

ACTIVE COMPARATOR

Renexin 1T bid for 12 weeks

Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)

Placebo

PLACEBO COMPARATOR

Placebo 1T bid for 12 weeks

Drug: Placebo

Interventions

Renexin (cilostazol 100mg + gingko biloba extract 80 mg) DRUG

Take Renexin 1T bid po medication for 8 weeks

Also known as: Renexin

Renexin

Placebo DRUG

Take placebo drug 1T bid po medication for 8 weeks

Also known as: Renexin

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo
• Visual analogue scale (VAS) score between 4 to 8

You may not qualify if:

• Showing signs of central lesion in MRI or neurologic exams
• central nystagmus or loss of consciousness with vertigo
• cerebellar symptoms such as ataxia, dysarthria, gait disturbance
• Diagnosed as peripheral vertigo such as benign paroxysmal positional vertigo, Meniere's disease, migrainous vertigo in recent 3 months
• Bilateral vestibular dysfunction
• Vestibular neuronitis symptom appeared in recent 6 months
• Chronic liver disease (ALT\>100 or AST\>100) or chronic kidney disease (Creatinine \> 3.0 mg)
• Blood Hemoglobin \< 10mg/dl (in male) or \< 8 mg/dl (in female)
• Contraindication for testing drug (ex. Pregnancy or breast feeding etc.)
• Taking antiepileptics such as phenobarbital, phenytoin, carbamazepine or rifampin in recent 2 weeks
• Taking cilostazol, gingko biloba for other disease
• Allergy/hypersensitivity to Renexin
• Severe drug toxicity when taking Renexin previously

Sponsors & Collaborators

• Jong Woo Chung: lead
• SK Chemicals Co., Ltd.: collaborator
• Asan Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Vestibular Neuronitis

Interventions

renexin; Cilostazol; Ginkgo Extract

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Jong Woo Chung, MD

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

KR (1)