Who may participate

Joining a clinical trial is an important and personal decision. Thank you for considering the OVATION study.

This study may be an option for your child if he or she:

•  is between 2–17 years old and weighs at least 10 kg (22 pounds)

•  has been diagnosed with ulcerative colitis for at least 12 weeks

•  is experiencing ulcerative colitis symptoms (flare-up)

 

Unfortunately, if your child has experienced a blocked bowel or has an ostomy pouch, then the OVATION study is not going to be right for them. But please talk to your doctor about other potential treatment options.

 

Please note there are other requirements for taking part in this study. The study doctor will be able to explain these to you.

Condition

Ulcerative Colitis

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Age

2-17 years

The age a person must be to participate in a clinical trial.
Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

If your child qualifies for the OVATION study, he or she will join approximately 120 other children and adolescents participating from countries around the world.

All study participants will be monitored frequently and supported by study site staff. Procedures to make sure participants are doing well will be required in this study. Some of these procedures include colonoscopies, physical examinations, as well as blood, urine, and stool samples. In addition, you and your child will complete health questions and a daily bowel movement diary.

Length of treatment

Up to 43 months

Length of treatment is the length of time the study participants will receive the study treatment.
Number of study visits

23 clinic visits

Each clinical trial’s design specifies the number of study visits and the total length of the trial.
Long-term follow up

One clinic visit about 4 weeks after the last dose, and one telephone call about 8 weeks after the last visit.

Some studies require the study team to stay in contact with the participant for a period of time after he or she completes the study. This long-term follow up is to collect safety information after study treatment has ended.

About ulcerative colitis

Ulcerative colitis is a condition in which the digestive system becomes inflamed. Inflammation is the body’s response to a physical injury or irritant. Inflammation may be experienced as redness, swelling, or pain. In ulcerative colitis, the inner lining of the large bowel (colon and rectum) becomes inflamed, and ulcers may develop on its surface.

Frequently Asked Questions

Can my child’s ulcerative colitis be cured?

Unfortunately, there is no treatment that can cure ulcerative colitis at this time. However, there are therapies that can help alleviate the symptoms, like inflammation.

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How will my child receive the study drug?

The study drug is tablets or a liquid to be given twice a day at home.

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How many visits would we have to make to the clinic?

Your child would attend up to 23 clinic visits. However, if temporary local restrictions mean study participants are unable to attend scheduled clinic visits, these may be carried out at their home or via telephone call instead.

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How can I tell if my child is having a flare-up?

The symptoms of a flare-up (relapse) may be slightly different from those your child had when he or she were first diagnosed with ulcerative colitis. If your child has a persistent tummy ache, fever, vomiting, diarrhea, blood in their stools, weight loss or general ill health, or if you are concerned in any way, you should consult your doctor.

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What if the study is not right for my child?

If the OVATION study is not right for your child, he or she will still receive treatment for ulcerative colitis. Please talk to your child’s doctor about treatment options.

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