Clinical Study Teenager Feedback Survey
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Clinical Study Summary
- The study is being conducted in teens with a condition that causes painful sores in the throat to see if the study medication will make the the sores go away and not come back. The study is 10 months long. Participants will be 12 – 17 years of age.
- Participants would need to swallow study medication for up to 6 months. For the first 2 months, they would swallow one capsule of study medication each day. For the next 4 months, they would swallow the contents of 2 different capsules of study medication (one capsule contains the real study and the other does not [placebo]) sprinkled into 2 tablespoons of applesauce
- Some tests are conducted before study participation to confirm that the participant meets all the study requirements, including a physical exam, blood tests, height, weight and blood pressure.
- A special test called an endoscopy, which confirms if the participant has a condition that causes sores in the throat, is conducted. An endoscopy is a procedure used to confirm if you have certain types of conditions that may be causing abdominal pain, nausea, vomiting, diarrhea and other gastrointestinal issues. It requires you to be sedated (put to sleep) during the test. After you are asleep, an endoscope — a thin, flexible tube with a light and camera on the end — is inserted into the mouth in order to see the throat, stomach and beginning of the small intestine. Small samples of tissue (called biopsies) are taken during the test, which are evaluated by a special lab in order to make the diagnosis of the condition you have.
- A second endoscopy will be conducted after the first 8 weeks of study medication dosing to see if the sores in the throat went away. A third endoscopy is done after the last 4 months of study medication dosing to see if the sores in the throat did not return
- Participants will use an electronic device, like an iPad, every day to confirm when study medication was taken, if there are any symptoms, if they needed to take another medication to relieve any symptoms and to fill out a questionnaire each week and another questionnaire 3 times during the study.
- Participants will visit the study center 6 times during the study for follow-ups. Participants will receive a telephone call from the study center 5 times during the study to see how they are doing.