Efficacy of Donepezil in Patients With Chronic Tinnitus

NCT ID: NCT07153991

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2025-12-09

Brief Summary

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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

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Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Group (donepezil)

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.

Group Type EXPERIMENTAL

Donepezil group

Intervention Type DRUG

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 group

35 Pacients with tinnitus received for 3 months placebo medication

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DRUG

35 Pacients with tinnitus received for 3 months placebo medication

Interventions

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Donepezil group

Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months

Intervention Type DRUG

Placebo group

35 Pacients with tinnitus received for 3 months placebo medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with chronic sensorineural tinnitus type

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Elaine Miwa Watanabe

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade De São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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U1111-1248-6988

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAAE 34251320.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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