Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02137382 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | PHASE3 | COMPLETED | 41 | — | — | Jan 1, 2014 | Aug 1, 2014 | Jan 22, 2016 | 7 | Hungary, Spain |
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...