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Label indication CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. FDA label
Creon · 1 trial · 1 indication
CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake
| Arm | Type | Description |
|---|---|---|
| Creon N, then Creon® | EXPERIMENTAL | Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. |
| Creon® , then Creon N | EXPERIMENTAL | Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. |
| Name | Type | Description |
|---|---|---|
| Creon® | DRUG | active comparator |
| Creon N | DRUG | experimental drug |
Inclusion Criteria: * Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject * Age ≥ 12 years * Subjects who are able to swallow capsules with...
Creon is used to treat pancreatic exocrine insufficiency due to cystic fibrosis. It is a pancreatic enzyme replacement therapy taken to help the body digest fats in people whose pancreas does not produce enough digestive enzymes. It is studied in patients 12 years of age and older with this condition.
Creon is developed and manufactured by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. Abbott is the company behind the Creon brand and its clinical development program in pancreatic exocrine insufficiency.
Creon has been evaluated in Phase 3 clinical development. Its Phase 3 program includes one completed trial, and no trials are currently active. The studies enrolled a total of 41 participants across the program.
Creon has been studied in the Phase 3 trial NCT02137382, a double-blind, randomized, multicenter, crossover study comparing Creon N and Creon on fat digestion in subjects 12 years of age and older with pancreatic exocrine insufficiency due to cystic fibrosis. The trial completed with 41 participants enrolled in Hungary and Spain.
Creon is also written as Creon (DR/GR) and Creon. The Phase 3 trial NCT02137382 compared Creon N with Creon, so the two names refer to formulations evaluated side by side in that study of fat digestion in cystic fibrosis-related pancreatic exocrine insufficiency.
The Phase 3 trial NCT02137382 was a double-blind, randomized, controlled, multicenter crossover study. It compared Creon N and Creon for their effect on fat digestion in participants 12 years of age and older with pancreatic exocrine insufficiency due to cystic fibrosis, and it enrolled 41 subjects in Hungary and Spain.