TinnitusPhase 3NCT01174979
Caroverin and Inner Ear Diseases
A Phase 3 study testing Caroverin in people with Tinnitus, run by Phafag AG at 1 site in Austria.
Trial summary
This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom. The study will investigate the transtympanic treatment with a 1,5 % caroverine solution. Each patient will undergo treatment for 2 cycles of 48 hours each. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Caroverin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to Aug 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged at least eighteen
- Written consent to take part in the study after receiving information from the trial physician
- One of the following illnesses:
- Decompensated tinnitus
- Sudden hearing loss
- Morbus Menière
Show all 9Show fewer
- Blast injury
- Presbyacusis with Tinnitus
- Chron. Otitis media
Who cannot join
- Patients who are not able to give their consent (e.g. dementia, coma, mental disability,…)
- Women of childbearing age who are not using adequate contraception or who are (or plan to become) pregnant (a pregnancy test must be carried out by a doctor once a month in Austria) or are lactating
- If there are solid reasons to doubt that the patient would be willing and able to cooperate
- Known intolerance of/hypersensitivity to caroverine
- Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study
- Pulse-synchronous tinnitus
Show all 16Show fewer
- Tinnitus caused by malposition of the jaw bone (bruxism)
- Eardrum perforation
- Subjects who have previously had a barotraumas, diving accidents or decompression sickness
- Retrocochlear hearing disorder
- Patients who have previously had a fracture of the petrous bone
- Subjects suffering from acute or chronic accompanying conditions which severely impede their general health (NYHA stage IV, cancer, HIV etc.)
- Accompanying conditions that according to the current state of scientific knowledge could affect the parameters used in this study to such an extent as to make it impossible to perform an objective assessment of those parameters, particularly ear conditions, including any conditions affecting the other ear or conditions like HI NYHA stage IV, cancer, HIV, Wallenberg Syndrome, massive Hypotension, Glaucoma.)
- Accompanying medication that according to the current state of scientific knowledge are likely to affect the measurement techniques used in this study or the results obtained (cytostatics, aminoglycoside antibiotics, loop diuretics (furosemide, etacrynic acid), psycho pharmaceuticals, muscle relaxants, benzodiazepines, salicylates, quinine, cortisone and/or caroverine within the three days preceding the start of the study)
- Drug treatment for tinnitus or sudden hearing loss (i.v. and oral) within seven days preceding the start of the study where the total duration of the course is less than four weeks
- Diseases or conditions that may be associated with an altered perception or processing of stimuli, e.g. mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine
This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom.
The study will investigate the transtympanic treatment with a 1,5 % caroverine solution.
Each patient will undergo treatment for 2 cycles of 48 hours each.
- Conditions
- Tinnitus
- Being tested
- Caroverin
- Keywords
- Morbus Meniere, Sudden hearing loss, Blast injury, Presbyacusis, Chron. Otitis Media
- Medical subject headings
- Tinnitus, Hearing Loss, Sudden, Blast Injuries, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaroverinDrug
treatment with eardrops 2 times for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Caroverin | Experimental | Not described Receives: Drug: Caroverin |
| Placebo | Placebo comparator | Not described Receives: Drug: Caroverin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.
Measured: treatment takes 5 days, follow up examination 4 weeks after
Secondary outcomes (4)
to investigate the time from the start of treatment to an improvement in tinnitus
Measured: treatment takes 5 days, follow up examination 4 weeks after
to investigate the efficacy of Caroverin depending the origin of tinnitus
Measured: treatment takes 5 days, follow up examination 4 weeks after
to investigate the safety of Caroverin treatment
Measured: treatment takes 5 days, follow up examination 4 weeks after
to investigate the impact of Caroverin treatment of quality of life
Measured: treatment takes 5 days, follow up examination 4 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2015 (estimated)
Why it stopped: due to less patient the study was suspended
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phafag AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Elsaesser, Dr., Principal investigator, Landeskrankenhaus Feldkirch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174979
- Sponsor's protocol ID
- 1-09
- Other IDs
- 2009-018046-38, 2009
- Status last verified
- Aug 2015
- First submitted
- 2 Aug 2010
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine
- ClinicalTrials.gov ID
- NCT01174979
- Acronym / sponsor ID
- 1-09
- Conditions
- Tinnitus
- Keywords
- Morbus Meniere, Sudden hearing loss, Blast injury, Presbyacusis, Chron. Otitis Media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: due to less patient the study was suspended
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Phafag AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (estimated)
- First posted
- 4 Aug 2010 (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.
This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom.
The study will investigate the transtympanic treatment with a 1,5 % caroverine solution.
Each patient will undergo treatment for 2 cycles of 48 hours each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caroverin | Experimental | Drug: Caroverin |
| Placebo | Placebo comparator | Drug: Caroverin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged at least eighteen
- Written consent to take part in the study after receiving information from the trial physician
- One of the following illnesses:
Key exclusion criteria (16 listed)
- Patients who are not able to give their consent (e.g. dementia, coma, mental disability,…)
- Women of childbearing age who are not using adequate contraception or who are (or plan to become) pregnant (a pregnancy test must be carried out by a doctor once a month in Austria) or are lactating
- If there are solid reasons to doubt that the patient would be willing and able to cooperate
- Known intolerance of/hypersensitivity to caroverine
- Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study
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 |
|---|---|---|
| Caroverintreatment with eardrops 2 times for 48 hours | Drug | Caroverin, Placebo |
Primary outcome
to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.
Time frame: treatment takes 5 days, follow up examination 4 weeks after
4 secondary outcomes
to investigate the time from the start of treatment to an improvement in tinnitus
Time frame: treatment takes 5 days, follow up examination 4 weeks after
to investigate the efficacy of Caroverin depending the origin of tinnitus
Time frame: treatment takes 5 days, follow up examination 4 weeks after
to investigate the safety of Caroverin treatment
Time frame: treatment takes 5 days, follow up examination 4 weeks after
to investigate the impact of Caroverin treatment of quality of life
Time frame: treatment takes 5 days, follow up examination 4 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Wolfgang Elsaesser, Dr. principal investigator
Landeskrankenhaus Feldkirch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caroverin in people with Tinnitus, run by Phafag AG at 1 site in Austria.
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 9 inclusion and 16 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: paused, as of the sponsor's last update on 7 Aug 2015. 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 Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale. (time frame: treatment takes 5 days, follow up examination 4 weeks after). 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 7 Aug 2015.