Clinical study on the
Eosinophilic esophagitis
Are you suffering from acute eosinophilic esophagitis with clinical symptoms? Do you have difficulties swallowing and inflammation of the esophagus? Then contact us.
Register for study
More information
Study information
Phase 2a
18 to 75 years
Cortisone therapy
Possible symptoms of an EoE:
- Difficulties swallowing, partly massive
- Pain behind the sternum
- Heartburn
- Cough
- Burping
- Diarrhea
- Nausea
- Vomiting
- Decreased appetite
What we are looking for
We are looking for patients between 18 and 75 years for a clinical study.
Precondition: The diagnosis of eosinophilic esophagitis and evidence of inflammation of the esophagus must be confirmed by an independent pathologist at the beginning of the study. See below for more information.
Treatment and more
Important info
Treatment
The participants are divided into two treatment groups.
Group 1 takes budesonide as a 2 mg tablet. A placebo tablet is taken as the second dose of the day. Group 2 takes budesonide as a 1 mg tablet twice a day.
During the treatment phase, neither doctors nor patients know whether the daily dose is reached by one or two doses. Therefore, this is referred to as a "double-blind study". After a 4-week follow-up period, a final visit takes place.
Time required
Study duration per patient: 11-14 weeks
The study begins with a screening phase of up to 4 weeks to assess eligibility for study participation (evidence of inflammation of the esophagus etc.). This is followed by a 6-week treatment phase with the aim of improving the symptoms and reducing the inflammation of the esophagus. For this purpose, the patients take one orodispersible tablet every morning and evening.
Aim of the study
Several studies have shown that treating EoE with budesonide, a glucocorticoid ("cortisone"), improves clinical symptoms and reduces inflammation. The currently recommended dose is one 1mg tablet taken twice a day for 6-12 weeks.
This study is investigating whether treating EoE with a daily intake of one 2 mg tablet is similarly safe and effective.
The participants are divided into two treatment groups.
Group 1 takes budesonide as a 2 mg tablet. A placebo tablet is taken as the second dose of the day. Group 2 takes budesonide as a 1 mg tablet twice a day.
During the treatment phase, neither doctors nor patients know whether the daily dose is reached by one or two doses. Therefore, this is referred to as a "double-blind study". After a 4-week follow-up period, a final visit takes place.
Study duration per patient: 11-14 weeks
The study begins with a screening phase of up to 4 weeks to assess eligibility for study participation (evidence of inflammation of the esophagus etc.). This is followed by a 6-week treatment phase with the aim of improving the symptoms and reducing the inflammation of the esophagus. For this purpose, the patients take one orodispersible tablet every morning and evening.
Several studies have shown that treating EoE with budesonide, a glucocorticoid ("cortisone"), improves clinical symptoms and reduces inflammation. The currently recommended dose is one 1mg tablet taken twice a day for 6-12 weeks.
This study is investigating whether treating EoE with a daily intake of one 2 mg tablet is similarly safe and effective.
Clinical study: Eosinophilic esophagitis
In this way you participate in the study
The study is carried out in several European countries, e. g. also in Germany and Canada. If you are interested in participating in a study for the treatment of EoE, please contact one of the study sites listed below. Thanks very much.
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FAQ on the EoE double-blind study
Due to its chemical properties, budesonide mainly acts in the mucous membrane of the esophagus and has little effect on the whole body. Therefore, the classic side effects of corticosteroids have only been observed with a significantly lower frequency and not with the same intensity. As with any therapy, however, side effects can also occur with treatment with budesonide. Therefore, during the study you are closely monitored so that any side effects that may occur can be treated quickly.
Yes, twice. Once at the beginning and once at the end of the study.
Adults aged 18-75 years suffering from acute eosinophilic esophagitis with clinical symptoms can participate in the study.
FAQ Clinical Studies
Frequently asked questions
A clinical trial is "any investigation involving human subjects", that tests new medical treatmentsdrugs or therapies to determine their safety and efficacy.
Clinical trials are crucial for the development and validation of new medical approaches, to enable advances in healthcare and improve existing treatments.
Clinical trials are conducted not only in hospitals, but also by physicians in private practice. Pharmaceutical companies are often the clients of such studies, but universities or hospitals can also initiate such studies. An educational interview will be conducted prior to potential participation. Here you will be informed about goals, methods, advantages and possible risks. After sufficient time to think about it, you can decide whether you want to participate in the clinical trial. Participation is always voluntary and can be terminated at any time without giving reasons. The initial consultation will be followed by the screening visit, during which your eligibility for the study will be assessed. If the assessment is positive, the baseline visit occurs, in which baseline values are recorded and then the study medication or a placebo is administered. During the treatment phase, regular visits are scheduled to monitor your health, the effectiveness of the medication, and any side effects. After the treatment phase, there is a follow-up phase to evaluate the long-term effects and safety of the medication.
Yes, the safety of the participants is a top priority. Clinical trials are carefully planned and monitored to minimize potential risks. Prior to participation, researchers must disclose all risks and potential benefits of a study, and participation is always on a voluntary basis.
