Creon - Scientific Information
|Condition:||Cystic Fibrosis, Chronic Pancreatitis, Pancreatic Exocrine Dysfunction|
|Ingredients:||pancreatin, cetyl alcohol, dimethicone 1000, FD&C Blue No. 2, gelatin, hypromellose phthalate, iron oxides, macrogol 4000, sodium lauryl sulphate, titanium dioxide, triethyl citrate|
|Proper name:||Pancreatin (synonyms include pancrelipase or pancreatic enzymes)|
|Chemical name:||Not applicable|
|Molecular formula and molecular mass:||Not applicable|
|Structural formula:||Not applicable|
|Physicochemical properties:||The active pharmaceutical ingredient of CREON MINIMICROSPHERES is pancreatin (also referred to as pancrelipase), an extract from porcine pancreas glands containing enzymes with lipolytic, amylolytic and proteolytic activity.|
Pancreatin is a slightly brown amorphous powder, with a faint characteristic odour, partly soluble in water and practically insoluble in alcohol and ether.
Pancreatic Exocrine Insufficiency
Overall 30 studies investigating the efficacy of CREON MINIMICROSPHERES capsules in patients with pancreatic exocrine insufficiency have been conducted. Ten of these were either placebo or baseline controlled studies performed in patients with cystic fibrosis, chronic pancreatitis or post surgical conditions.
In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show superiority of CREON MINIMICROSPHERES over placebo on the primary efficacy parameter, the coefficient of fat absorption (CFA).
The CFA determines the percentage of fat that is absorbed into the body taking into account fat intake and fecal fat excretion. In the placebo-controlled pancreatic exocrine insufficiency studies, the mean CFA (%) was higher with CREONMINIMICROSPHERES treatment (83.0%) as compared to placebo (62.6%). In all studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with CREONMINIMICROSPHERES was similar to the mean CFA values for CREONMINIMIC ROSPHERES in the placebo-controlled studies.
In the placebo-controlled studies, the mean percentage of days without the clinical symptoms of abdominal pain and flatulence was highest in the CREON MINIMICROSPHERES group as compared to placebo. Vice versa, the mean percentage of days with abdominal pain or flatulence of most different intensities (mild, moderate, severe) was lowest with CREON MINIMICROSPHERES compared to placebo. The mean percentage of days with hard and formed/normal stools was highest with CREON MINIMICROSPHERES treatment (6.6% and 59.8%, respectively) compared with placebo (4.8% and 38.1%, respectively). The percentage of days with soft and watery stools was always lowest with CREONMINIMICROSPHERES treatment compared to placebo. In all performed studies, irrespective of etiology, an improvement was also shown in disease specific symptomatology (stool frequency, stool consistency, flatulence).
In cystic fibrosis (CF) the efficacy of CREON MINIMICROSPHERES was demonstrated in 288 pediatric patients covering an age range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values exceeded 80% on CREON MINIMICROSPHERES comparably in all pediatric age groups.
Non-clinical data show no relevant acute, subchronic or chronic toxicity. Studies on genotoxicity, carcinogenicity or toxicity to reproduction have not been performed.