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

SHINE-ON (AMAZ)

Conditions: Ulcerative Colitis; Crohn’s Disease

Principal Investigator: Sameer Lapsia, MD

Study Specifications: SHINE-ON is an extension study to SHINE-1, evaluating the long-term safety and effectiveness of mirikizumab in children and adolescents with UC or Crohn’s Disease.

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