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Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus (SECIST)

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ClinicalTrials.gov Identifier: NCT02737670
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon

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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Drug: Sulodexide Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
Study Start Date : August 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Adverse effects [ Time Frame: Up to 40 days ]
    reporting adverse effects by the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737670


Locations
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Lebanon
St Jospeh University
Beirut, Lebanon
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Investigators
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Principal Investigator: Elias Eter, MD Faculty of Medicine - St Joseph University

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Responsible Party: Dr Joseph Maarrawi, Head of the Laboratory of Neurosciences, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT02737670     History of Changes
Other Study ID Numbers: SULO-TINNITUS
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs