Tinnitus, SubjectivePhase 2SECISTNCT02737670
Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
A Phase 2 study testing Sulodexide in people with Tinnitus, Subjective, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Sulodexide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteLebanon
- Study dates
- Aug 2014to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Conductive hearing loss
- Mixed hearing loss
- Meniere's disease
- Systemic vascular disease
- Diabetic disease
- Vestibular schwannoma
Show all 9Show fewer
- Cerebello-pontine angle tumors
- Pulsatile tinnitus
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
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.
Read the 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- Sulodexide, Placebo
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulodexideDrug
25 mg morning and evening for 40 days
PlaceboDrug
1 tablet morning and evening for 40 days
| Study group | Role | What they receive |
|---|---|---|
| Sulodexide | Active comparator | Sulodexide 25 mg twice per day for 40 days Receives: Drug: Sulodexide |
| Placebo | Placebo comparator | 1 tablet twice per day for 40 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
Assessment of changes in THI questionnaire score between Day 40 and 0
Measured: At day 0 and at 40 days
Secondary outcomes (2)
Mini Tinnitus Questionnaire (Mini-TQ)
Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
Measured: At day 0 and at 40 days
Adverse effects
reporting adverse effects by the patient
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon
- Investigators
- Elias Eter, MD, Principal investigator, Faculty of Medicine - St Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737670
- Sponsor's protocol ID
- SULO-TINNITUS
- Acronym
- SECIST
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT02737670
- Acronym / sponsor ID
- SECIST / SULO-TINNITUS
- Conditions
- Tinnitus, Subjective
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulodexide | Active comparator | Drug: SulodexideSulodexide 25 mg twice per day for 40 days |
| Placebo | Placebo comparator | Drug: Placebo1 tablet twice per day for 40 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Conductive hearing loss
- Mixed hearing loss
- Meniere's disease
- Systemic vascular disease
- Diabetic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulodexide25 mg morning and evening for 40 days | Drug | Sulodexide |
| Placebo1 tablet morning and evening for 40 days | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Mini Tinnitus Questionnaire (Mini-TQ)
Time frame: At day 0 and at 40 days
Adverse effects
Time frame: Up to 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Eter, MD principal investigator
Faculty of Medicine - St Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulodexide in people with Tinnitus, Subjective, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: At day 0 and at 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.