Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus (SECIST)

St Joseph University, Beirut, Lebanon

Status and phase: Completed; Phase 2

Conditions: Tinnitus, Subjective

Treatments: Drug: Placebo; Drug: Sulodexide

Study type: Interventional

Funder types: Other

Identifiers

NCT02737670

SULO-TINNITUS

Details and patient eligibility

About

The objective of this prospective randomized and double blind controlled study is to evaluate the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic subjective tinnitus.

Full description

Patients with chronic idiopathic subjective tinnitus, since at least 1 year, re recruited from our Ear, Nose and Throat (ENT) clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1- Sulodexide 25 mg for 40 days 2- Placebo for 40 days. Clinical evaluation of the patient is performed; tinnitus is assessed according to Tinnitus Handicap Inventory score, Mini Tinnitus Questionnaire score. Adverse effects are also noted. Patients are followed at 40 days post-treatment and outcome measures are assessed.

Enrollment: 126 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tinnitus for minimum of 1 year
• Absence of psychiatric or neurological diseases
• Absence of any disease that explains tinnitus
• Noise-induced hearing loss
• Cochlear and retro-cochlear damage

Exclusion criteria

• Conductive hearing loss
• Mixed hearing loss
• Meniere's disease
• Systemic vascular disease
• Diabetic disease
• Vestibular schwannoma
• Cerebello-pontine angle tumors
• Pulsatile tinnitus
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Sulodexide

Active Comparator group

Description:

Sulodexide 25 mg twice per day for 40 days

Treatment:

Drug: Sulodexide

Placebo

Placebo Comparator group

Description:

1 tablet twice per day for 40 days

Treatment:

Drug: Placebo