Ongoing Clinical Trials for Injection Site Pain
This article provides information about 1 ongoing clinical trial investigating treatment options related to injection site pain. The trial focuses on managing inner ear conditions using intratympanic (into the ear) injections, where injection site pain may occur as a potential side effect of the treatment method.
Clinical trial locations
Study on Meniere’s Disease: Comparing Methylprednisolone and Placebo for Patients with Unilateral Meniere’s Disease
This clinical trial is investigating whether methylprednisolone injections are more effective than placebo in reducing vertigo attacks in patients with Menière’s disease. The treatment involves injections directly into the ear, a method called intratympanic injection, which may cause injection site pain.
Main inclusion criteria:
- Diagnosed with unilateral Menière’s disease (affecting only one ear)
- Over 18 years old
- Experienced at least 4 vertigo attacks in the last 6 months
- Both males and females can participate
Main exclusion criteria:
- No diagnosis of unilateral Menière’s disease
- Members of vulnerable populations (such as pregnant women, children, or those unable to give consent)
- Other medical conditions that might interfere with the study
- Currently participating in another clinical trial
- Allergies or adverse reactions to the study medication
- Recent surgery or medical procedures that might affect the study
- Unable to follow study procedures or attend follow-up visits
Trial focus and goals: The main goal of this study is to determine whether intratympanic methylprednisolone is more effective than a placebo in reducing the frequency of vertigo attacks over a one-year period. The trial will also monitor participants’ quality of life, including aspects related to dizziness and tinnitus (ringing in the ears). The study tracks the use of various medications administered through ear injections and assesses their impact on hearing and overall well-being. Additionally, the trial evaluates the use of metoclopramide to manage nausea and vomiting, which are common symptoms during vertigo attacks.
Investigational drug: The primary investigational drug is methylprednisolone, a corticosteroid medication administered at a dosage of 62.5 mg/ml through intratympanic injection. Methylprednisolone works by reducing inflammation and suppressing the immune response in the inner ear, which may help decrease the frequency of vertigo episodes. The medication is delivered directly to the affected area through injections into the ear, allowing for targeted treatment. The study also considers other medications such as dexamethasone, triamcinolone, and gentamicin, which are also administered through intratympanic injections.
What to expect during the trial: Participants will first undergo an initial assessment to confirm eligibility, including a review of medical history and physical examination. During the treatment phase, participants will receive either methylprednisolone or placebo injections into the ear at specified intervals. Throughout the trial, participants will have regular check-ups and may be asked to complete questionnaires about their quality of life and symptoms. At the end of the trial, a final assessment will evaluate the treatment’s effectiveness.
Summary
Currently, there is 1 ongoing clinical trial related to injection site pain, located in the Netherlands. This trial focuses on Menière’s disease treatment using intratympanic injections, where injection site pain may occur as a consequence of the injection method. The study investigates methylprednisolone, a corticosteroid medication, comparing it to placebo to determine its effectiveness in reducing vertigo attacks. The trial is designed to provide insights into the effectiveness and safety of ear injection treatments, which are relevant to understanding and managing potential injection site pain associated with this delivery method.
