Sulodexide Efficacy in Chronic Idiopathic Subjective Tinn... | NCT02737670

Studies
Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

NCT02737670

Sponsor

St Joseph University, Beirut, Lebanon

Status

Completed

Last Update Posted

Sep 14, 2017Actual

Enrollment

126Actual

Phase

Phase 2

Conditions

Tinnitus, Subjective

Interventions

Sulodexide
Placebo

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Mar 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Apr 3, 2016

First Submission Date that Met QC Criteria

Apr 10, 2016

First Posted Date

Apr 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2017

Last Update Posted Date

Sep 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Joseph Maarrawi, Head of the Laboratory of Neurosciences, St Joseph University, Beirut, LebanonPrincipal Investigator

Lead Sponsor

St Joseph University, Beirut, LebanonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sulodexide	Drug	25 mg morning and evening for 40 days	Sulodexide
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elias Eter, MD	Faculty of Medicine - St Joseph University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Jospeh University		Beirut			Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014012	Tinnitus

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C007858	glucuronyl glucosamine glycan sulfate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided