TinnitusPhase 4NCT07153991
Efficacy of Donepezil in Patients With Chronic Tinnitus
A Phase 4 study testing Donepezil group in people with Tinnitus, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Donepezil group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Nov 2021to 9 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic sensorineural tinnitus type
Who cannot join
- pregnancy, arrhythmia, donepezil allergy, yelow dye allergy, otitis or any ear inflamatory diseases, patients taking any medication for dementia, convulsive diseases, asthma, patients taking any of these medications: carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin, ketoconazole, quinidine.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.
Read the detailed description
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
- Conditions
- Tinnitus
- Being tested
- Donepezil group, Placebo group
- Keywords
- tinnitus, donepezil
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil groupDrug
Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months
Placebo groupDrug
35 Pacients with tinnitus received for 3 months placebo medication
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (donepezil) | Experimental | 35 Participants with tinnitus received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months. Receives: Drug: Donepezil group |
| Placebo group | Placebo comparator | 35 Pacients with tinnitus received for 3 months placebo medication Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
tinnitus improvement
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start19 Nov 2021
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Elaine Miwa Watanabe, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153991
- Sponsor's protocol ID
- CAAE 34251320.5.0000.0068
- Other IDs
- U1111-1248-6988
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Donepezil in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT07153991
- Acronym / sponsor ID
- CAAE 34251320.5.0000.0068
- Conditions
- Tinnitus
- Keywords
- tinnitus, donepezil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- 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.
This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.
Detailed description
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (donepezil) | Experimental | Drug: Donepezil group35 Participants with tinnitus received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months. |
| Placebo group | Placebo comparator | Drug: Placebo group35 Pacients with tinnitus received for 3 months placebo medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with chronic sensorineural tinnitus type
Key exclusion criteria (1 listed)
- pregnancy, arrhythmia, donepezil allergy, yelow dye allergy, otitis or any ear inflamatory diseases, patients taking any medication for dementia, convulsive diseases, asthma, patients taking any of these medications: carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin, ketoconazole, quinidine.
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 |
|---|---|---|
| Donepezil groupParticipants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months | Drug | Intervention Group (donepezil) |
| Placebo group35 Pacients with tinnitus received for 3 months placebo medication | Drug | Placebo group |
Primary outcome
tinnitus improvement
Time frame: 3 months
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil group in people with Tinnitus, run by University of Sao Paulo at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
tinnitus improvement (time frame: 3 months). 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 4 Sep 2025.