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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00662675 | A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | PHASE3 | COMPLETED | 40 | — | — | Aug 1, 2008 | Feb 1, 2009 | May 9, 2014 | 11 | United States, Canada |
Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Pancrease MT 10.5 or MT 21 Pancrease MT capsules for maximum dose of 10 000 lipase units / Kg / day |
| 002 | EXPERIMENTAL | Placebo for Pancrease MT 10.5 or MT 21 Capsules with Pancrease MT excipients without the active enzymes |
| Name | Type | Description |
|---|---|---|
| Pancrease MT 10.5, or MT 21 | DRUG | Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day |
| Placebo for Pancrease MT 10.5 or MT 21 | DRUG | Capsules with Pancrease MT excipients without the active enzymes |
Inclusion Criteria: * Have a diagnosis of CF documented by sweat chloride results (\>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces * Have do...