Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for pancreatic exocrine insufficiency due to cystic fibrosis. It is a small molecule gastrointestinal treatment developed by Abbott Laboratories. The drug is designed to address fat digestion issues in patients with this condition, and it has been studied in a clinical trial setting.
Creon targets pancreatic exocrine insufficiency, a condition where the pancreas does not produce enough digestive enzymes. While the specific molecular target is not detailed, the drug works to improve fat digestion in patients with cystic fibrosis who have this insufficiency.
Abbott Laboratories (ticker: ABT) develops Creon. The company has conducted clinical research on the drug for pancreatic exocrine insufficiency due to cystic fibrosis, including a Phase 3 trial completed in Hungary and Spain.
Creon is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a double-blind, randomized, multicenter, cross-over study. The drug is investigational and not yet approved, as it remains in clinical development.
Creon has one completed Phase 3 trial, NCT02137382, which studied its effect on fat digestion in subjects aged 12 years and older with pancreatic exocrine insufficiency due to cystic fibrosis. The trial enrolled 41 participants and was conducted in Hungary and Spain.