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Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus (SECIST)

Primary Purpose

Tinnitus, Subjective

Status
Completed
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Sulodexide
Placebo
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St Jospeh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sulodexide

Placebo

Arm Description

Sulodexide 25 mg twice per day for 40 days

1 tablet twice per day for 40 days

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI)
Assessment of changes in THI questionnaire score between Day 40 and 0

Secondary Outcome Measures

Mini Tinnitus Questionnaire (Mini-TQ)
Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
Adverse effects
reporting adverse effects by the patient

Full Information

First Posted
April 3, 2016
Last Updated
September 13, 2017
Sponsor
St Joseph University, Beirut, Lebanon
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1. Study Identification

Unique Protocol Identification Number
NCT02737670
Brief Title
Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
Acronym
SECIST
Official Title
Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sulodexide
Arm Type
Active Comparator
Arm Description
Sulodexide 25 mg twice per day for 40 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet twice per day for 40 days
Intervention Type
Drug
Intervention Name(s)
Sulodexide
Intervention Description
25 mg morning and evening for 40 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet morning and evening for 40 days
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
Assessment of changes in THI questionnaire score between Day 40 and 0
Time Frame
At day 0 and at 40 days
Secondary Outcome Measure Information:
Title
Mini Tinnitus Questionnaire (Mini-TQ)
Description
Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
Time Frame
At day 0 and at 40 days
Title
Adverse effects
Description
reporting adverse effects by the patient
Time Frame
Up to 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Eter, MD
Organizational Affiliation
Faculty of Medicine - St Joseph University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Jospeh University
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

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