Last updated on May 2018

The ORBIT 1 Clinical Research Study for Eosinophilic Esophagitis (EoE)

Brief description of study

The ORBIT 1 Clinical Research Study for Eosinophilic Esophagitis (EoE)

Detailed Study Description

The ORBIT 1 clinical research study is now looking for patients with eosinophilic esophagitis (EoE) or suspected EoE.

What is EoE?

Usually, your immune system does a great job of keeping you healthy. But, sometimes, it reacts to things it shouldn’t—like food. EoE is thought to be a type of allergy that is often caused by food or things that you inhale in the environment. When someone with EoE eats or even inhales some things in the environment, a type of white blood cell called eosinophils collects in the esophagus. As these cells aren’t normally there, they can cause symptoms such as swallowing difficulties, stomach pain, and vomiting.

Why is this study being conducted?

Because no medication has been approved to treat EoE, the study team is conducting a clinical research study to see if an investigational drug called budesonide oral suspension (BOS) can help.

Who is eligible for the ORBIT 1 study?

Potential participants must be 11 to 55 years old and have a history of problems when they eat, such as swallowing difficulties, abdominal pain, heartburn, vomiting, food impaction, or weight loss. If you do not have a current diagnosis of EoE, but experience signs and symptoms of EoE, you may be eligible to participate if a diagnosis of EoE is confirmed during the screening process for the study.

What will happen if I take part?

Participants will be asked to take the investigational drug orally twice a day and will need to keep a daily record of symptoms. Participation in the study lasts between 23 and 26 weeks. Each participant will also visit a study clinic 6 times (around once per month) to allow the study team to monitor his/her health using various assessments.

Why should I consider participating?

There is no charge to participate in this clinical research study. All study-related medical care and procedures are provided free of charge and reimbursement for expenses (such as meals and travel) may be available. The results of this study may provide information that could help improve available treatment in the future.

If you or someone you know has EoE, or suspects it, you may be interested in finding out more about this new clinical research study.

Clinical Study Identifier: TX146196

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Recruitment Status: Closed

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