NCT02737670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

April 3, 2016

Last Update Submit

September 13, 2017

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Handicap Inventory (THI)

    Assessment of changes in THI questionnaire score between Day 40 and 0

    At day 0 and at 40 days

Secondary Outcomes (2)

  • Mini Tinnitus Questionnaire (Mini-TQ)

    At day 0 and at 40 days

  • Adverse effects

    Up to 40 days

Study Arms (2)

Sulodexide

ACTIVE COMPARATOR

Sulodexide 25 mg twice per day for 40 days

Drug: Sulodexide

Placebo

PLACEBO COMPARATOR

1 tablet twice per day for 40 days

Drug: Placebo

Interventions

SulodexideDRUG

25 mg morning and evening for 40 days

Sulodexide
PlaceboDRUG

1 tablet morning and evening for 40 days

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Conductive hearing loss
  • Mixed hearing loss
  • Meniere's disease
  • Systemic vascular disease
  • Diabetic disease
  • Vestibular schwannoma
  • Cerebello-pontine angle tumors
  • Pulsatile tinnitus
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Jospeh University

Beirut, Lebanon

Location

MeSH Terms

Conditions

Tinnitus

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elias Eter, MD

    Faculty of Medicine - St Joseph University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Neurosciences

Study Record Dates

First Submitted

April 3, 2016

First Posted

April 14, 2016

Study Start

August 1, 2014

Primary Completion

March 1, 2017

Study Completion

August 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations

LE(1)