thepeerstudy.net

A clinical research study is a carefully controlled investigation to help determine if a medicine is safe and effective.

By participating, you and your child will contribute to medical research. This may help researchers answer important questions about possible treatments for your child and others suffering with the same illness.

There is no monetary cost. If your child is eligible to participate in this study, he or she will receive:

• Careful medical assessments of his/her medical condition at no cost.
• Frequent medical evaluations beyond the standard of care and what medical insurance will typically cover.
• Access to medical specialists who treat children with EoE.
• Study medicine at no charge.

The study center will discuss this with you if your child qualifies to participate.

The medicine being studied is "budesonide" (bu-des-o-nide). It is given as a liquid and swallowed each day. Budesonide has been FDA-approved for asthma and hay fever in children and adults, but not for EoE.

This study is supported by Meritage Pharma, Inc, which is committed to the development of a treatment for pediatric EoE. More information about Meritage Pharma is available by clicking here.

If selected to participate, your child will receive frequent study-related check-ups, ongoing study-related medical care, and laboratory tests conducted by the study staff to monitor his/her health.

If your child is selected to participate in this clinical study, you may wish to tell his/her personal doctor. You also may wish to let your child's personal doctor know the duration of the study and the name of the doctor(s) at the study center.

You can request that the study staff follow-up with your child's personal doctor to explain participation in more detail.

Yes. If you and/or your child no longer wants to participate in the study, you can discontinue the study at any time. Your child may be asked to make a final study visit as a safety precaution.

This is a form that ensures that you have given permission for your child to participate in the clinical study. The Informed Consent process is a discussion among you, your child and the study doctor and nurse about the study procedures, benefits, and risks. This discussion takes place before you and your child agree to join the study.

You will be given a consent form to read. You should ask questions about any part of the consent form you do not understand. If you decide for your child to take part in the study, you will be asked to sign the consent form. Your child may also be asked to give "assent" or, in other words, agree to participate in the study. Even if these forms are signed, you and/or your child can change your mind and stop participating in the study at any time.

Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, require that clinical trial volunteers sign an informed consent form that has been previously reviewed and approved by an Institutional Review Board (IRB) before entering a study. The IRB is an independent review board responsible for protecting the rights of those participating in research.

As with all drugs, there can be benefits as well as risks. Your child's EoE may or may not get better during the study. The most common risk for swallowing budesonide is thrush, a yeast infection that can cause soreness of the mouth and throat. There are medicines to treat thrush if it occurs. The staff at the clinical study center will discuss the potential benefits and side effects of the treatment with you during the Informed Consent process.

All information collected for research purposes identifies your child only by initials and a number. Please be assured that the study staff will do everything possible to keep any personal information confidential. These protections will be discussed in further detail during the Informed Consent process.

Your child will have a 3 in 4 (75%) chance of receiving the study medicine with budesonide and a 1 in 4 (25%) chance of receiving placebo. You and your child will not know to which of the groups he/she has been assigned.

The placebo looks exactly like the study medicine, but does not contain any budesonide. Studies designed with a placebo are necessary. In this way, the effect of the study medicine can be compared with the effect of no medicine.

Each participant group is of equal importance to this study's success. Each group and each patient makes a valuable contribution to advancing EoE research and knowledge.