A Phase 3 interventional study of Meclizine and Dimenhydrinate in Vertigo, Peripheral, sponsored by Apsen Farmaceutica S.A.. Completed at 7 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Apsen Farmaceutica S.A. · Phase 3, Interventional, and Treatment
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.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's enrollment of 292 is above the median of 73 across 138 interventional studies indexed under Vertigo.
Browse Vertigo studies →Apsen Farmaceutica S.A. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Meclizine 25 mg, tablets
Drug: Meclizine
Dimenhydrinate 50 mg, soft Capsgel
Drug: Dimenhydrinate
25 mg, 3 times per day up to 30 days
Also known as: Meclin
50 mg, 3 times per day up to 30 days
Also known as: Dramin
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.
Time frame: up to 30 days
Quality of Life Questionnaire DHI - Dizziness Handicap Inventory, validated for the Brazilian population
Evaluation of life quality
Time frame: up to 30 days
Stanford and Epworth Sleepiness Scale
Evaluation of somnolence (baseline measurement)
Time frame: up to 30 days
Variation of the intensity of each of the 10 symptoms
Evaluation of the variation of the intensity of each of the 10 symptoms that make up VS, along the visits
Time frame: up to 30 days
Duration of treatment (days from V0)
Evaluation of the duration of tratement from each group
Time frame: up to 30 days
Adherence rate to treatment
Evaluation of adherence rate from each group throughout the study
Time frame: up to 30 days
Visual analogue scale (VAS) for subjects and for investigators
For the subjective assessment of the participant and investigator's research on the treatment applied in 1,2,3 visits and final (VF);
Time frame: up to 30 days
Participants Percentage with any symptoms classified as moderate (score ≥2)
Evaluation of participants percentage with any symptoms classified as moderate on the VS Scale on the follow-up visit, held 7 ± 2 days after the final inspection (VF). through the study.
Time frame: Since last Visit
Analysis of Adverse Events
Evaluation of any Adverse Event ou Serious Adverse Event recorded after the signing of the Informed Consent ( IC) and until the end of the study
Time frame: After the signature of SICF
Clinical and Physical findings
Evaluation of any changes in clinical / physical assessment findings since baseline
Time frame: After the signature of SICF
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Apr 2017, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Meclizine
Apsen Farmaceutica S.A.