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The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | One intratympanic injection of latanoprost (Day1) |
|
| Group 2 | Placebo Comparator | One intratympanic injection of placebo |
|
| Group 3 | Experimental | Three intratympanic injections of latanoprost (Day 1, 2 and 3) |
|
| Group 4 | Placebo Comparator | Three intratympanic injections of placebo (Day 1, 2 and 3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in speech discrimination score in noise from Baseline | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in speech discrimination score in noise from Baseline | 3 months | |
| Change in pure tone audiometry from Baseline | 3 months | |
| Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikael Karlberg, MD, PhD | Lund University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falu Lasarett | Falun | Sweden | ||||
| Sahlgrenska Universitetssjukhuset |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| D034381 | Hearing Loss |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| 3 months |
| Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period | 3 months |
| Change in proportion of days with vertigo attacks from run-in period | 3 months |
| Comparison of number of drop attacks in each treatment arm | 3 months |
| Evaluation of adverse events and vital signs as measure of safety and tolerability | 3 months |
| Gothenburg |
| Sweden |
| Blekinge Hospital | Karlskrona | Sweden |
| Centralsjukhuset i Karlstad | Karlstad | Sweden |
| Centralsjukhuset i Kristianstad | Kristianstad | Sweden |
| Linköping University Hospital | Linköping | Sweden |
| Sunderby Sjukhus | Luleå | Sweden |
| Lund University Hospital | Lund | Sweden |
| University Hospital Örebro | Örebro | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Västmanlands Sjukhus i Västerås | Västerås | Sweden |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |