Summary:
If your child has ulcerative colitis (UC), you may want to consider the PACE clinical research study.
What is ulcerative colitis?
Ulcerative colitis (UC) is a chronic disease of the colon, where the lining of the colon becomes inflamed and forms ulcers. Typical symptoms of UC include:
- Loose and urgent bowel movements
- Frequent diarrhea
- Blood in your stool
- Stomach pain
There is no known cause of UC. Researchers and doctors are trying to understand what causes the disease, and more research is needed about how medications for UC work in children.
What is the purpose of the PACE study?
The goal of the PACE study is to learn whether an investigational medication is safe and if it works well in children and adolescents aged 5 to 17 who have mild to moderate UC or are in remission.
The investigational medication is already approved in multiple countries to treat UC in adults. Because it has not been approved for children and adolescents, it is considered investigational in this study.
What is the investigational medication?
The investigational medication, called MMX® mesalamine/mesalazine, works by reducing inflammation in the lining of the colon. The medication is released gradually, so that active ingredients can reach and target the colon.
In addition to the investigational medication, a non-active tablet called placebo may be given at the same time. Placebo looks like the investigational medication but has no active ingredients.
What will my child have to do?
If eligible, your child’s participation in the study may last from about 2 to 10 months, during which your child may have a maximum of 10 visits to the site. At these visits, your child will have study-related tests and procedures. You and your child will also need to fill out a diary before your child’s bedtime during the five days before each study visit.
The site staff will discuss all the study requirements with you in more detail, and your child will be closely monitored during his or her participation in the study.
Who can participate?
Your child may be eligible to participate in the PACE study if he or she:
- Is 5 to 17 years of age
- Has mild to moderate UC or is in remission
- Does not have Crohn’s disease
The study doctor or staff will review other requirements for your child to participate.
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.
The information learned from the study and your child’s participation may help improve future treatment options for children and adolescents with UC.
Study participation is voluntary. If you choose to allow your child to participate, he or she may leave the study at any time for any reason. The study doctor and staff will be available to help your child throughout the study and to address any questions you or your child may have.