Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus (SECIST)

September 13, 2017 updated by: Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • St Jospeh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sulodexide
Sulodexide 25 mg twice per day for 40 days
Drug: Sulodexide
25 mg morning and evening for 40 days
Placebo Comparator: Placebo
1 tablet twice per day for 40 days
Drug: Placebo
1 tablet morning and evening for 40 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: At day 0 and at 40 days
Assessment of changes in THI questionnaire score between Day 40 and 0
At day 0 and at 40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Tinnitus Questionnaire (Mini-TQ)
Time Frame: At day 0 and at 40 days
Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
At day 0 and at 40 days
Adverse effects
Time Frame: Up to 40 days
reporting adverse effects by the patient
Up to 40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Joseph University, Beirut, Lebanon

Investigators

  • Principal Investigator: Elias Eter, MD, Faculty of Medicine - St Joseph University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 10, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SULO-TINNITUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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