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TerminatedNCT01895400REREVUpdated Feb 17, 2016

Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy

A Phase 3 interventional study of Renexin (cilostazol 100mg + gingko biloba extract 80 mg) and Placebo in Recurrent Vestibulopathy, sponsored by Jong Woo Chung. Terminated at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by Jong Woo Chung · Phase 3, Interventional, and Treatment

Why this study was terminated
Participant enrollment is much delayed. The whole design needs to be revised.
Phase
Phase 3
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Recurrent Vestibulopathy

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Keywords

  • Renexin for Recurrent Vestibulopathy
03

In context

Vestibular Neuronitis

34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.

This study's enrollment of 26 is below the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.

Browse Vestibular Neuronitis studies →

Lead sponsor

Jong Woo Chung is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (>100 or AST>100) or chronic kidney disease (Creatinine > 3.0 mg)
  • Blood \< 10mg/dl (in male) or \< 8 mg/dl (in female)
  • 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/ to Renexin
  • Severe drug toxicity when taking Renexin previously
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Renexin

    Renexin 1T bid for 12 weeks

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

  • Placebo comparator
    Placebo

    Placebo 1T bid for 12 weeks

    Drug: Placebo

Interventions

  • DrugRenexin (cilostazol 100mg + gingko biloba extract 80 mg)

    Take Renexin 1T bid po medication for 8 weeks

    Also known as: Renexin

  • DrugPlacebo

    Take placebo drug 1T bid po medication for 8 weeks

    Also known as: Renexin

06

What researchers measure

Primary outcomes

  1. equilibrium score of dynamic posturography

    compared with pretreatment equilibrium score

    Time frame: after 8 weeks of treatment

Secondary outcomes

  1. dizziness handicap inventory

    compared with pretreatment DHI score

    Time frame: at 4 weeks, 8 weeks after treatment

  2. visual analogue scale (VAS) of vertigo

    compared with pretreatment VAS score

    Time frame: at 4 weeks, 8 weeks after treatment

  3. Questionnaire for Quality of life (SF36)

    compared with pretreatment SF36 score

    Time frame: at 4 weeks, 8 weeks after treatment

07

Study locations

1 site
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01895400
Lead sponsor
Jong Woo Chung
Responsible party
Jong Woo Chung (MD, Asan Medical Center) — Sponsor-investigator
First posted
Jul 10, 2013
Start date
Jul 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 17, 2016

Study contacts

Jong Woo Chung, MD
study chair · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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