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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02415959 | Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | PHASE2 | COMPLETED | 70 | — | — | Mar 1, 2015 | Jul 1, 2015 | Apr 4, 2016 | 17 | Czechia, Hungary +2 |
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 IR low dose | EXPERIMENTAL | Creon IR 300 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units) |
| Creon IR medium dose | EXPERIMENTAL | Creon IR 1,200 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units) |
| Creon IR high dose | EXPERIMENTAL | Creon IR 2,400 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units) |
| Creon IR maximum dose | EXPERIMENTAL | Creon IR 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) |
| Creon® (DR/GR) | ACTIVE_COMPARATOR | Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat/day, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units) |
| Name | Type | Description |
|---|---|---|
| Creon IR | DRUG | - |
| Creon® (DR/GR) | DRUG | - |
Inclusion Criteria: 1. Subject has voluntarily signed and dated the Informed Consent Form (ICF). For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the Independent Ethics Committee (IEC), assent will be given by the subje...