Recurrent VestibulopathyPhase 3REREVNCT01895400
Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
A Phase 3 study testing Renexin (cilostazol 100mg + gingko biloba extract 80 mg) in people with Recurrent Vestibulopathy, run by Jong Woo Chung at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Recurrent Vestibulopathy
- What is being tested?
- Renexin (cilostazol 100mg + gingko biloba extract 80 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo
- Visual analogue scale (VAS) score between 4 to 8
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
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
- 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.
- 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.
- Conditions
- Recurrent Vestibulopathy
- Being tested
- Renexin (cilostazol 100mg + gingko biloba extract 80 mg), Placebo
- Keywords
- Renexin for Recurrent Vestibulopathy
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renexin (cilostazol 100mg + gingko biloba extract 80 mg)Drug
Also called Renexin
Take Renexin 1T bid po medication for 8 weeks
PlaceboDrug
Also called Renexin
Take placebo drug 1T bid po medication for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Renexin | Active comparator | Renexin 1T bid for 12 weeks Receives: Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg) |
| Placebo | Placebo comparator | Placebo 1T bid for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
equilibrium score of dynamic posturography
compared with pretreatment equilibrium score
Measured: after 8 weeks of treatment
Secondary outcomes (3)
dizziness handicap inventory
compared with pretreatment DHI score
Measured: at 4 weeks, 8 weeks after treatment
visual analogue scale (VAS) of vertigo
compared with pretreatment VAS score
Measured: at 4 weeks, 8 weeks after treatment
Questionnaire for Quality of life (SF36)
compared with pretreatment SF36 score
Measured: at 4 weeks, 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Participant enrollment is much delayed. The whole design needs to be revised.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent VestibulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jong Woo Chung
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd., Asan Medical Center
- Responsible party
- Sponsor-investigator, Jong Woo Chung, Asan Medical Center
- Investigators
- Jong Woo Chung, MD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895400
- Sponsor's protocol ID
- AMC-2013-0165
- Other IDs
- 20130055275
- Acronym
- REREV
- Status last verified
- Feb 2016
- First submitted
- 5 Jul 2013
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Randomized, Parallel Group, Placebo-controlled Exploratory Study on the Effect of Renexin Tablet in Patients With Recurrent Vestibulopathy
- ClinicalTrials.gov ID
- NCT01895400
- Acronym / sponsor ID
- REREV / AMC-2013-0165
- Conditions
- Recurrent Vestibulopathy
- Keywords
- Renexin for Recurrent Vestibulopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant enrollment is much delayed. The whole design needs to be revised.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jong Woo ChungUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd., Asan Medical Center
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.
Detailed description
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renexin | Active comparator | Drug: Renexin (cilostazol 100mg + gingko biloba extract 80 mg)Renexin 1T bid for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1T bid for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recurrent vestibulopathy patient with symptoms more than 3 months of recurrent vertigo
- Visual analogue scale (VAS) score between 4 to 8
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renexin (cilostazol 100mg + gingko biloba extract 80 mg)Also: RenexinTake Renexin 1T bid po medication for 8 weeks | Drug | Renexin |
| PlaceboAlso: RenexinTake placebo drug 1T bid po medication for 8 weeks | Drug | Placebo |
Primary outcome
equilibrium score of dynamic posturography
Time frame: after 8 weeks of treatment
compared with pretreatment equilibrium score
3 secondary outcomes
dizziness handicap inventory
Time frame: at 4 weeks, 8 weeks after treatment
visual analogue scale (VAS) of vertigo
Time frame: at 4 weeks, 8 weeks after treatment
Questionnaire for Quality of life (SF36)
Time frame: at 4 weeks, 8 weeks after treatment
Results and safety
The study was stopped early (reason given: Participant enrollment is much delayed. The whole design needs to be revised.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Woo Chung, MD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renexin (cilostazol 100mg + gingko biloba extract 80 mg) in people with Recurrent Vestibulopathy, run by Jong Woo Chung at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Participant enrollment is much delayed. The whole design needs to be revised.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
equilibrium score of dynamic posturography (time frame: after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.