Ongoing Clinical Trials for Otitis Media
Currently, there is 1 ongoing clinical trial related to otitis media and associated inner ear conditions. This trial is investigating treatments for Menière’s disease, an inner ear disorder that can cause vertigo and hearing problems, and is being conducted in the Netherlands.
Clinical trial locations
Study on Meniere’s Disease: Comparing Methylprednisolone and Placebo for Patients with Unilateral Meniere’s Disease
This trial is focused on testing a treatment for Menière’s disease, a disorder affecting the inner ear that can cause episodes of vertigo (a sensation of spinning or dizziness), hearing loss, ringing in the ears (tinnitus), and a feeling of fullness or pressure in the ear. The condition typically affects only one ear and can significantly impact daily life due to unpredictable vertigo attacks.
Main inclusion criteria:
- Must have been diagnosed with unilateral Menière’s disease (affecting only one ear)
- Must be over 18 years old
- Must have experienced at least 4 vertigo attacks in the last 6 months
- Both males and females can participate
Main exclusion criteria:
- Patients who do not have unilateral Menière’s disease
- Those who are part of vulnerable populations (such as pregnant women or individuals unable to give consent)
- Patients with other medical conditions that might interfere with the study
- Those currently participating in another clinical trial
- Patients with allergies or adverse reactions to the study medication
- Those who have had recent surgery or medical procedures that might affect the study
- Patients unable to follow study procedures or attend follow-up visits
Focus and goal: The trial aims to determine whether methylprednisolone injections are more effective than a placebo in reducing the frequency of vertigo attacks in patients with Menière’s disease. The treatment is delivered through intratympanic injection, which means the medication is injected directly into the ear. This method allows the medication to target the affected area more effectively. The study will monitor participants over a one-year period and assess not only the frequency of vertigo attacks but also the quality of life, including aspects related to dizziness and tinnitus.
Investigational drug: Methylprednisolone is a corticosteroid medication that works by reducing inflammation and suppressing the immune response in the inner ear. In this trial, it is administered at a dosage of 62.5 mg/ml through direct injection into the ear. The goal is to reduce the inflammation that contributes to vertigo episodes. The study also considers other medications such as dexamethasone, triamcinolone, and gentamicin, which are also given through ear injections, as well as metoclopramide to help manage nausea and vomiting during vertigo attacks.
What participants can expect: Upon joining the trial, participants will undergo an initial assessment to confirm eligibility, which includes a review of medical history and a physical examination. During the treatment phase, participants will receive ear injections at specified intervals. Throughout the trial, regular check-ups and assessments will monitor health and response to treatment, and participants may be asked to complete questionnaires about their symptoms and quality of life. At the end of the trial, a final assessment will evaluate treatment effectiveness.
Summary
Currently, there is one ongoing clinical trial focused on treating Menière’s disease, an inner ear disorder related to otitis media. This trial is being conducted in the Netherlands and is investigating whether methylprednisolone, a corticosteroid medication injected directly into the ear, can reduce the frequency of vertigo attacks more effectively than a placebo. The study targets adults who have experienced frequent vertigo episodes and aims to provide insights into managing this challenging condition that significantly affects quality of life.
