|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02737670 |
|
Date of registration:
|
03/04/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
SECIST |
|
Scientific title:
|
Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus |
|
Date of first enrolment:
|
August 2014 |
|
Target sample size:
|
126 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02737670 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Lebanon
| | | | | | | |
|
Contacts
|
|
Name:
|
Elias Eter, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Faculty of Medicine - St Joseph University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Tinnitus, Subjective
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Sulodexide
|
|
Primary Outcome(s)
|
|
Tinnitus Handicap Inventory (THI)
[Time Frame: At day 0 and at 40 days]
|
|
Secondary Outcome(s)
|
|
Adverse effects
[Time Frame: Up to 40 days]
|
|
Mini Tinnitus Questionnaire (Mini-TQ)
[Time Frame: At day 0 and at 40 days]
|
|
Secondary ID(s)
|
|
SULO-TINNITUS
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|