Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Creon micro
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 therapy in the gastrointestinal therapeutic area. The drug is currently in Phase 3 clinical development.
Abbott Laboratories (NYSE: ABT) is developing Pancreatin. The drug is being studied for pancreatic insufficiency and pancreatic exocrine insufficiency. It is currently in Phase 3 clinical trials, with studies conducted in India and Russia.
Pancreatin is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Clinical trials have been completed for the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis and in children younger than four years with pancreatic exocrine insufficiency.
Pancreatin has been studied in two Phase 3 clinical trials. NCT00705978 evaluated Creon 40,000 for pancreatic exocrine insufficiency due to chronic pancreatitis in India, enrolling 62 participants. NCT01747330 evaluated Creon Micro in children younger than four years with pancreatic exocrine insufficiency in Russia, enrolling 40 participants.
Pancreatin is the active ingredient in the drug product Creon. Clinical trials for Pancreatin have been conducted using the brand names Creon 40,000 and Creon Micro. These trials evaluated the treatment of pancreatic exocrine insufficiency in adult and pediatric populations.