M14-658
Condition: Ulcerative Colitis (UC)
Type of Research: Prospective
Principal Investigator:Nancy Yokois, MD
Study Specifications: Ulcerative Colitis (UC) is a chronic inflammatory disease of the rectum and/or large intestine. Typical symptoms may include bloody diarrhea and frequent urges to the bathroom. This study will assess the effectiveness, safety and pharmacokinetics of investigational drug ABT-494 in pediatric subjects ages 2-17 with moderately to severely active UC.
REMODEL-CD
Condition: Chron's Disease (CD)
Type of Research: Multi-Site, open-label
Principal Investigator:Rana Ammoury, MD
Study Specifications: Chron’s disease (CD) is an illness that brings GI inflammation and other unwanted GI symptoms. There is an unmet need for a pediatric intervention to treat CD. This study will test whether precision infliximab dosing is effective in achieving remission compared to patients receiving conventional infliximab dosing.
TAK-390MR_204
Condition: Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
Type of Research: Prospective
Principal Investigator: Michael Konikoff, MD
Study Specifications: Gastroesophageal Reflux Disease (GERD) is the passage of gastric contents into the esophagus. Reflux disease comprises of a range of disorders including erosive and non-erosive GERD. The prevalence of GERD is becoming more and more recognized in the pediatric population. Patients who present with GERD as children are more likely to continue symptoms into adulthood. This study will assess the pharmacokinetics (PK) and safety of delayed-release capsules (dexlansoprazole) in participants aged 2-11 years old as a new therapy to treat acid-related disorders such as non-erosive GERD.
Email:CRU@chkd.org
Phone: (757) 668-5416
TAK-390MR_205
Condition: Erosive Gastroesophageal Reflux Disease (GERD)
Type of Research: Prospective
Principal Investigator: Michael Konikoff, MD
Study Specifications: GERD summary mirrors specifications from TAK-390MR_204 above, specifically for erosive GERD. This study will assess the pharmacokinetics (PK) and safety of delayed-release capsules (dexlansoprazole) in participants aged 2-11 years old as a new therapy to treat erosive GERD.
Email:CRU@chkd.org
Phone: (757) 668-5416
DEVELOP
Conditions: Inflammatory Bowel Diseases; Crohn’s Disease, Ulcerative Colitis, Indeterminate Colitis
Type of Research: Observational
Study Specifications: REMICADE® (infliximab) has been approved for the treatment of children and adults with Crohn’s disease (CD) and adults with ulcerative colitis (US). The DEVELOP registry aims to provide additional information on pediatric IBD following the approval of Remicade indication for pediatric CD in the US and EU.
Email:CRU@chkd.org
Phone: (757) 668-5416
