SECIST: Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

• Sponsor: St Joseph University, Beirut, Lebanon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02737670
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 3.5

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Aug 1, 2014
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tinnitus Handicap Inventory (THI) [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) [At day 0 and at 40 days]

   Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0

2. Adverse effects [Up to 40 days]

   reporting adverse effects by the patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Jospeh University	Beirut		Lebanon

Sponsors and Collaborators

• St Joseph University, Beirut, Lebanon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Joseph Maarrawi, Head of the Laboratory of Neurosciences, St Joseph University, Beirut, Lebanon
• ClinicalTrials.gov Identifier: NCT02737670
• Other Study ID Numbers: SULO-TINNITUS
• First Posted: Apr 14, 2016
• Last Update Posted: Sep 14, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Tinnitus; Glucuronyl glucosamine glycan sulfate

Study Results

No Results Posted as of Sep 14, 2017