Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy (REREV)

This study has been terminated.
(Participant enrollment is much delayed. The whole design needs to be revised.)
Sponsor:
Collaborators:
SK Chemicals Co.,Ltd.
Asan Medical Center
Information provided by (Responsible Party):
Jong Woo Chung, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01895400
First received: July 5, 2013
Last updated: February 14, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.

Condition Intervention Phase
Recurrent Vestibulopathy
Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • equilibrium score of dynamic posturography [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
    compared with pretreatment equilibrium score


Secondary Outcome Measures:
  • dizziness handicap inventory [ Time Frame: at 4 weeks, 8 weeks after treatment ] [ Designated as safety issue: No ]
    compared with pretreatment DHI score

  • visual analogue scale (VAS) of vertigo [ Time Frame: at 4 weeks, 8 weeks after treatment ] [ Designated as safety issue: No ]
    compared with pretreatment VAS score

  • Questionnaire for Quality of life (SF36) [ Time Frame: at 4 weeks, 8 weeks after treatment ] [ Designated as safety issue: Yes ]
    compared with pretreatment SF36 score


Enrollment: 26
Study Start Date: July 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Renexin
Renexin 1T bid for 12 weeks
Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
Take Renexin 1T bid po medication for 8 weeks
Other Name: Renexin
Placebo Comparator: Placebo
Placebo 1T bid for 12 weeks
Drug: Placebo
Take placebo drug 1T bid po medication for 8 weeks
Other Name: Renexin

Detailed Description:
  1. Study design

    • Among patients who visitied for recurrent vertigo more than 3 months, patients will be included after ruling out other peripheral vertigo through history taking, physical examination, Dix-Hallpike test, head-thrust test.
    • Included patients will go through permission, laboratory tests (CBC, chemical battery, coagulation battery, urine HCG (only women of childbearing age), posturography. During patients selection period for inclusion(2 weeks), taking medication for vertigo is prohibited.
    • Included patients will be randomized to Treatment group (Renexin) and Placebo group.
    • All patients before treatment will do dizziness handicap inventory(DHI), visual analogue scale (VAS) for vertigo, questionnaire for quality of life (SF36).
    • After 4 weeks(+-~ 3 days) of drug administration, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects.
    • After 8 weeks(+-~ 3 days) of drug administration, posturography, DHI, VAS for vertigo, SF36 will be done for drug compliance and side effects.
    • For control of severe vertigo during drug administration, Valium 2mg can be used as a salvage treatment, and number of valium administration will be checked at every visit.
  2. Statistical analysis

    • As a statistical analysis, paired T-test will be used to compare equilibrium score, DHI, VAS, SF-36. When p-value is <0.05, it will be considered as significant difference.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895400

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Jong Woo Chung
SK Chemicals Co.,Ltd.
Asan Medical Center
Investigators
Study Chair: Jong Woo Chung, MD Asan Medical Center
  More Information

Responsible Party: Jong Woo Chung, MD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01895400     History of Changes
Other Study ID Numbers: AMC-2013-0165  20130055275 
Study First Received: July 5, 2013
Last Updated: February 14, 2016
Health Authority: Korea: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: This study is decided to be terminated. Among 26 participants, 15 finished medication according to the protocol. I am not sure that these data can be analyzed because data is still unblinded.

Keywords provided by Asan Medical Center:
Renexin for Recurrent Vestibulopathy

Additional relevant MeSH terms:
Vestibular Neuronitis
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases
Nervous System Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 21, 2016