Donepezil´s effects in patientes with long standing Tinnitus

Efficacy of Donepezil in patients with chronic Tinnitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-8td9hs

Enrollment

Unknown

Registered

2020-11-03

Start date

2021-01-29

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Interventions

50 patients with tinnitus will take the medicine donepezil 5 mg for 30 days and then, 10 mg for 60 days. After a wash-out for 30 days, they will start the next step: take a placebo for 90 days. Neith

Drug

Q000187

Eligibility

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adults over 18 years old; with tinnitus one-sided or bilateral, for more than 6 months, caused by sensorineural hearing loss

Exclusion criteria

Exclusion criteria: Pregnant women, nursing mothers;known hypersensitivity to donepezil or piperidine derivatives; with external and or middle ear pathologies; other tympanograms than type A; with mixed or conductive hearing loss; using medications similar to donepezil (memantine, rivastigmine, galantamine) or less than 30 days of use; patients with supraventricular abnormalities of cardiac conduction or bradycardia, seizure, schizophrenia, ulcer, asthma or severe COPD; patients using carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin, ketoconazole and quinidine.

Design outcomes

Primary

Measure	Time frame
Improvement is expected from patients with tinnitus who will use the medication comparing to placebo group. The methods Student's t test and ANOVA analysis will be used, before and after placebo and active drug therapy, for quantitative variables. Statistical significance level of 0.05 or 5% will be adopted for two-tailed samples and study power of 95%. The qualitative variables will be described by their frequency of presentation.	—

Measure

Time frame

Improvement is expected from patients with tinnitus who will use the medication comparing to placebo group. The methods Student's t test and ANOVA analysis will be used, before and after placebo and active drug therapy, for quantitative variables. Statistical significance level of 0.05 or 5% will be adopted for two-tailed samples and study power of 95%. The qualitative variables will be described by their frequency of presentation.

—

Secondary

Measure	Time frame
The memory improvement is expected from patients who will use the medication comparing to placebo group. The methods Student's t test and ANOVA analysis will be used, before and after placebo and active drug therapy, for quantitative variables. Statistical significance level of 0.05 or 5% will be adopted for two-tailed samples and study power of 95%. The qualitative variables will be described by their frequency of presentation.	—

Measure

Time frame

The memory improvement is expected from patients who will use the medication comparing to placebo group. The methods Student's t test and ANOVA analysis will be used, before and after placebo and active drug therapy, for quantitative variables. Statistical significance level of 0.05 or 5% will be adopted for two-tailed samples and study power of 95%. The qualitative variables will be described by their frequency of presentation.

—

Countries

Brazil

Contacts

Public Contactelaine watanabe

Faculdade Medicina USP

elainemiwa@yahoo.com.br11997791404

Outcome results

None listed

Source: REBEC (via WHO ICTRP)