Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

Tinnitus, Subjective Clinical Trial

— SECIST  

Official title:

Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737670
• Other study ID #: SULO-TINNITUS
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2016
• Last updated: September 13, 2017
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: April 2017
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Sulodexide
25 mg morning and evening for 40 days
• Placebo
1 tablet morning and evening for 40 days

Locations

Country	Name	City	State
Lebanon	St Jospeh University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory (THI)	Assessment of changes in THI questionnaire score between Day 40 and 0	At day 0 and at 40 days
Secondary	Mini Tinnitus Questionnaire (Mini-TQ)	Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0	At day 0 and at 40 days
Secondary	Adverse effects	reporting adverse effects by the patient	Up to 40 days