Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON®) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: An open-label, multicentre, single-treatment-arm study

Clinical Drug Investigation

Volumn 30, Issue 6, 2010, Pages 351-364

  Graff, Gavin R ^a   McNamara, John ^b   Royall, James ^c   Caras, Steven ^d   Forssmann, Kristin ^e  

^a PENN STATE MILTON S HERSHEY MEDICAL CENTER   (United States)

^b Childrens Hospitals and Clinics of Minnesota   (United States)

^c UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^d Solvay Pharmaceuticals Inc   (Netherlands)

^e Solvay Pharmaceuticals GmbH   (Germany)

Author keywords

Cystic fibrosis; Exocrine pancreatic insufficiency; Pancreatic enzymes; Pancrelipase; Therapeutic use; Treatment

Indexed keywords

KREON;

ABDOMINAL PAIN; ACUTE OTITIS MEDIA; ARTICLE; BRONCHITIS; CAREGIVER; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONJUNCTIVITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CYSTIC FIBROSIS; DECREASED APPETITE; DEFECATION; DELAYED RELEASE FORMULATION; DIAPER DERMATITIS; DIARRHEA; DRUG CAPSULE; DRUG EFFICACY; DRUG FEVER; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; FECES COMPOSITION; FEMALE; FLATULENCE; GROUPS BY AGE; HUMAN; INFANT; IRRITABILITY; MALE; MULTICENTER STUDY; OPEN STUDY; PANCREAS EXOCRINE INSUFFICIENCY; PATIENT COMPLIANCE; PATIENT MONITORING; PRESCHOOL CHILD; PRIORITY JOURNAL; RHINORRHEA; SCREENING; SIDE EFFECT; SKIN CANDIDIASIS; STANDARD; STOOL CONSISTENCY; TOOTH ERUPTION; TREATMENT DURATION; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; VIRUS INFECTION; VOMITING;

CAPSULES; CHILD, PRESCHOOL; CYSTIC FIBROSIS; DELAYED-ACTION PREPARATIONS; ENZYME REPLACEMENT THERAPY; EXOCRINE PANCREATIC INSUFFICIENCY; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INFANT; MALE; PANCRELIPASE;

EID: 77952037726     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11533390-000000000-00000     Document Type: Article

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