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Pancrease MT 10.5, or MT 21 · 1 trial · 4 indications
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...
Pancrease MT 10.5 and MT 21 are used for exocrine pancreatic insufficiency, a condition where the pancreas does not produce enough digestive enzymes. They are being studied for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiency, which can cause steatorrhea and malabsorption syndromes.
Pancrease MT 10.5 and MT 21 are being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ.
Pancrease MT 10.5 and MT 21 are in Phase 3 clinical development. They are investigational drugs and have not been approved by the FDA. The Phase 3 trial has been completed.
Pancrease MT 10.5 and MT 21 have one completed Phase 3 trial, NCT00662675, which studied the efficacy and tolerability of pancrelipase microtablet capsules for cystic fibrosis-dependent exocrine pancreatic insufficiency. The trial enrolled 40 participants in the United States and Canada.
Pancrease MT 10.5 and MT 21 are small molecule drugs. They contain pancrelipase, a combination of digestive enzymes that help break down fats, proteins, and carbohydrates in the intestine, compensating for the lack of pancreatic enzymes in exocrine pancreatic insufficiency.