Vertigo, PeripheralPhase 3NCT02112578
Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin
A Phase 3 study testing Meclizine and Dimenhydrinate in people with Vertigo, Peripheral, run by Apsen Farmaceutica S.A. at 7 sites in Brazil.
Trial summary
Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate) to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of treatment; Evaluation of impact on quality of life in vertigo; Compare the intensity of daytime sleepiness in the two treatment groups; Compare the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vertigo, Peripheral
- What is being tested?
- Meclizine and Dimenhydrinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 7 sitesBrazil
- Study dates
- 1 Nov 2016to 1 Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years and less than 65;
- Presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the VS range ;
- Participants who are able to swallow tablets / capsules;
- Participants able to understand the guidance and care of this study and cooperative ;
- Participants with the requisite understanding, in accordance with Good Clinical Practice Research Document of the Americas.
Who cannot join
- Use of meclizine or dimenidrynate in the actual event or in the past 15 days;
- Use of alcohol in the past 48 hours;
- Presence of vomiting which prevent the ingestion of tablets;
- Pregnancy or breastfeeding;
- Presence of clinical condition that determines contraindication to the active substances : convulsions , suspected intracranial compressive processes , closed-angle glaucoma , prostatic adenoma with urinary disorders , liver diseases , endocrine , renal, and / or uncontrolled cardiovascular , Parkinson's disease, porphyria, know history of hipersensibility to the Actives or Excipients from the study medications;
- Malignancies History , even if no evidence of active disease for less than five years . Those without active disease for more than five years may be included;
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- Uncontrolled systemic arterial hypertension ( > 140/90 mmHg );
- Decompensated diabetes mellitus (blood glucose at any time > 200 mg / dL );
- Participants with asthma or chronic obstructive pulmonary disease;
- Participants making use of antihistamines with anti-vertigo effect ( betahistine, meclizine , diphenidol ) , drugs with antagonist calcium channel action ( cinnarizine , flunarizine ) , anticholinergic drugs ( metoclopramide , dimenhydrinate , meclizine , diphenidol , scopolamine, ondansetron, granisetron ) , antiseizure drugs ( diazepam , clonazepam , carbamazepine ) and other central nervous system depressants;
- Participants with central origin vertigo or non-vestibular;
- Participants with positional benign positional paroxysmal vertigo (bppv).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Brazil7 sites
Alergoalpha
Barueri, São Paulo, 06454010
Clinilive
Maringá, Paraná
Pesquisare Saude S/S Ltda
Santo André, São Paulo, 09080110
ISPEM
São José dos Campos, São Paulo, 12243280
CCBR SP
São Paulo, São Paulo, 04063001
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo
Clinica de Alergia MarttiAntila
Sorocaba, São Paulo, 18040425
About this study
Official title: " National, Phase III, Radomized, Double-Blind, Double -Dummy, Controlled, Parallel to Evaluate Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) Soft Gel Capsules in the Control of Acute Vertigo Symphtoms From Peripheral Origin"
- Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate) to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of treatment;
- Evaluation of impact on quality of life in vertigo;
- Compare the intensity of daytime sleepiness in the two treatment groups;
- Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;
- Compare the duration of treatment in both treatment groups;
- Compare Adehence;
- Compare the level of satisfaction from each group from the investigators and the subjects;
- Adverse events;
Read the detailed description
It is a prospective interventional study arms parallel , active -controlled , non-inferiority . Participants selected for the study should be of both sexes , aged over 18 years and less than 65, which meet all the inclusion criteria and did not fit any exclusion criteria , and agree to all the purposes of the study. Participants are divided into two according to the randomization treatment groups 1:1.
The study should take no longer than 30 days to be completed with the amount of 6 visits (7±2 days): V0 radomization; V1, V2, V3 andV4(FV) are Evaluation visits and One Follow up visit 7±2 days after the Final Visit.
- Conditions
- Vertigo, Peripheral
- Being tested
- Meclizine, Dimenhydrinate
- Keywords
- Vertigo, Meclizine, dimenhydrinate, Peripheral Origin
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeclizineDrug
Also called Meclin
25 mg, 3 times per day up to 30 days
DimenhydrinateDrug
Also called Dramin
50 mg, 3 times per day up to 30 days
| Study group | Role | What they receive |
|---|---|---|
| Meclizine | Experimental | Meclizine 25 mg, tablets Receives: Drug: Meclizine |
| Dimenhydrinate | Active comparator | Dimenhydrinate 50 mg, soft Capsgel Receives: Drug: Dimenhydrinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertigo Score (VS)
Evaluation of non inferiority by measuring 10 symptoms of vertigo : distasia and instability when walking ; totter ; spinning sensation; tendency to fall; Continuous floating feeling ; floating sensation to change position ; floating sensation to bow down ; floating sensation when standing up ; floating sensation traveling on any means of transport; floating sensation with head movement ; floating sensation with eye movement. Each symptom is graduated in a semi -quantitative 5-point scale : 0 = no symptoms ; 1 = mild symptoms ; 2 = moderate symptoms ; 3 = strong symptoms ; 4 = very strong symptoms in all visits that the subject accomplishes.
Measured: up to 30 days
Secondary outcomes (1)
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Evaluation of life quality
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start1 Nov 2016
- Primary completion1 Apr 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertigo, PeripheralStudies 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
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norton Sayeg, PhD, Principal investigator, CCBR SP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112578
- Sponsor's protocol ID
- APS 002/2013
- Other IDs
- BRA15APS002-2015, U1111-1149-6768
- Status last verified
- Feb 2023
- First submitted
- 10 Apr 2014
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " National, Phase III, Radomized, Double-Blind, Double -Dummy, Controlled, Parallel to Evaluate Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) Soft Gel Capsules in the Control of Acute Vertigo Symphtoms From Peripheral Origin"
- ClinicalTrials.gov ID
- NCT02112578
- Acronym / sponsor ID
- APS 002/2013
- Conditions
- Vertigo, Peripheral
- Keywords
- Vertigo, Meclizine, dimenhydrinate, Peripheral Origin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 14 Apr 2014 (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.
- Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate) to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of treatment;
- Evaluation of impact on quality of life in vertigo;
- Compare the intensity of daytime sleepiness in the two treatment groups;
- Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;
- Compare the duration of treatment in both treatment groups;
- Compare Adehence;
- Compare the level of satisfaction from each group from the investigators and the subjects;
- Adverse events;
Detailed description
It is a prospective interventional study arms parallel , active -controlled , non-inferiority . Participants selected for the study should be of both sexes , aged over 18 years and less than 65, which meet all the inclusion criteria and did not fit any exclusion criteria , and agree to all the purposes of the study. Participants are divided into two according to the randomization treatment groups 1:1.
The study should take no longer than 30 days to be completed with the amount of 6 visits (7±2 days): V0 radomization; V1, V2, V3 andV4(FV) are Evaluation visits and One Follow up visit 7±2 days after the Final Visit.
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 |
|---|---|---|
| Meclizine | Experimental | Drug: MeclizineMeclizine 25 mg, tablets |
| Dimenhydrinate | Active comparator | Drug: DimenhydrinateDimenhydrinate 50 mg, soft Capsgel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged over 18 years and less than 65;
- Presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the VS range ;
- Participants who are able to swallow tablets / capsules;
- Participants able to understand the guidance and care of this study and cooperative ;
- Participants with the requisite understanding, in accordance with Good Clinical Practice Research Document of the Americas.
Key exclusion criteria (12 listed)
- Use of meclizine or dimenidrynate in the actual event or in the past 15 days;
- Use of alcohol in the past 48 hours;
- Presence of vomiting which prevent the ingestion of tablets;
- Pregnancy or breastfeeding;
- Presence of clinical condition that determines contraindication to the active substances : convulsions , suspected intracranial compressive processes , closed-angle glaucoma , prostatic adenoma with urinary disorders , liver diseases , endocrine , renal, and / or uncontrolled cardiovascular , Parkinson's disease, porphyria, know history of hipersensibility to the Actives or Excipients from the study medications;
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 |
|---|---|---|
| MeclizineAlso: Meclin25 mg, 3 times per day up to 30 days | Drug | Meclizine |
| DimenhydrinateAlso: Dramin50 mg, 3 times per day up to 30 days | Drug | Dimenhydrinate |
Primary outcome
Vertigo Score (VS)
Time frame: up to 30 days
Evaluation of non inferiority by measuring 10 symptoms of vertigo : distasia and instability when walking ; totter ; spinning sensation; tendency to fall; Continuous floating feeling ; floating sensation to change position ; floating sensation to bow down ; floating sensation when standing up ; floating sensation traveling on any means of transport; floating sensation with head movement ; floating sensation with eye movement. Each symptom is graduated in a semi -quantitative 5-point scale : 0 = no symptoms ; 1 = mild symptoms ; 2 = moderate symptoms ; 3 = strong symptoms ; 4 = very strong symptoms in all visits that the subject accomplishes.
1 secondary outcome
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Norton Sayeg, PhD principal investigator
CCBR SP
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meclizine and Dimenhydrinate in people with Vertigo, Peripheral, run by Apsen Farmaceutica S.A. at 7 sites in Brazil.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertigo Score (VS) (time frame: up to 30 days). 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 8 Sep 2026.