1044122- Concentration vs. Time of Proton Pump Inhibitors in Pediatric Patients
This study is being done to evaluate information about how children metabolize PPIs. Information will be collected and compiled regarding the child’s PPI medications and the results of his or her serum concentration vs. time results for PPIs prescribed for EER and GERD.
This study is open until December 29, 2006.
Inclusion criteria:
- Children between the ages of 0-18 years already receiving a PPI for treatment of GERD or disorders related to EER.
- Children who have had a PPI concentration vs. time serum levels drawn as a part of their standard treatment.
Exclusion criteria:
- Adults over the ages of 0-18 years placed on a PPI for treatment of GERD or disorders related to EER.
- Healthy children without EER or GERD between the ages of 0-18 years
- Children who have not had PPI concentration vs. time serum levels drawn as a part of their standard treatment.
What Is Involved in the Study?
- Patient eligibility determined.
- The legally authorized representative is contacted on behalf of patient for consent for participation in study. A Health Insurance Portability Accountability Act (HIPAA) Authorization and Informed Consent will be reviewed and signed.
- The legally authorized representative will be asked to discuss participation in the study with his/her child if 7 years or older.
- A researcher will then obtain the needed information from your child’s health record.
- Data will be compiled and analyzed.
- Reports, articles and/or presentations will be prepared.
You may ask more questions about the study at any time. You can reach a member of the Outcomes of Pediatric Patients Previously Treated with Proton Pump Inhibitors study by calling 573-884-4112, you may leave a message 24 hours a day. A study staff member will return your call during our regular office hours. We are open Monday through Friday between 8 am and 4 pm CST or contact us by email at
info@marci-kids.com.