Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pancreatin · 2 trials · 2 indications
change from baseline at day 84
change from baseline at day 84
Average daily stool frequency during treatment period: Number of bowel movements per day
Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.
| Arm | Type | Description |
|---|---|---|
| Creon micro, minimicrospheres | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pancreatin | DRUG | Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used |
| Placebo | DRUG | placebo |
Inclusion Criteria: * Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms Exclusion Criteria: * Ileus or acute abdomen * history of fibrosing colonopathy * history of distal ileal obstruction without surgery * solid organ transplant ...
Pancreatin is used for pancreatic insufficiency and pancreatic exocrine insufficiency, conditions where the pancreas does not produce enough digestive enzymes. It is being developed by Abbott Laboratories as a small molecule treatment in the gastrointestinal therapeutic area.
Abbott Laboratories, traded as ABT on the stock exchange, is developing Pancreatin. The drug is intended for patients with pancreatic insufficiency and pancreatic exocrine insufficiency.
Pancreatin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.
Pancreatin has been studied in two Phase 3 trials. NCT00705978 evaluated Creon 40,000 for pancreatic exocrine insufficiency due to chronic pancreatitis in 62 patients in India. NCT01747330 assessed Creon Micro in children under four years with pancreatic exocrine insufficiency in Russia.
Yes, Pancreatin is the same as Creon. Clinical trials for Pancreatin include studies of Creon 40,000 and Creon Micro, which are brand names for the drug.