TinnitusPhase 4NCT04798391
Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus
A Phase 4 study testing Dexamethasone in people with Tinnitus, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus. Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to May 2021
- Phase
- Phase 4
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- score 20 or above on modified tinnitus handicap inventory
Who cannot join
- head trauma, tympanic membrane perforation, depression, ear surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dexamethasone With Lignocaine for Alleviation of Tinnitus
Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus.
Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). The dose was repeated twice at weekly intervals. All patients were re assessed on Modified Tinnitus Handicap Inventory two weeks after third Intratympanic administration.
- Conditions
- Tinnitus
- Being tested
- Dexamethasone
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Lignocaine
Steroids and analgesics
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone with lignocaine | Experimental | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus relief
Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Mar 2021
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FARAH AFZAL, Combined Military Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798391
- Sponsor's protocol ID
- CMHQ
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dexamethasone With Lignocaine for Alleviation of Tinnitus
- ClinicalTrials.gov ID
- NCT04798391
- Acronym / sponsor ID
- CMHQ
- Conditions
- Tinnitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 15 Mar 2021 (actual)
- 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.
Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus.
Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). The dose was repeated twice at weekly intervals. All patients were re assessed on Modified Tinnitus Handicap Inventory two weeks after third Intratympanic administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone with lignocaine | Experimental | Drug: Dexamethasone |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- score 20 or above on modified tinnitus handicap inventory
Key exclusion criteria (1 listed)
- head trauma, tympanic membrane perforation, depression, ear surgery
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 |
|---|---|---|
| DexamethasoneAlso: LignocaineSteroids and analgesics | Drug | Dexamethasone with lignocaine |
Primary outcome
Tinnitus relief
Time frame: 2 weeks
Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Tinnitus, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2021. 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 Pakistan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 relief (time frame: 2 weeks). 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 15 Mar 2021.