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Pancrelipase in combination with Ensure Plus · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Pancrelipase in combination with Ensure Plus 3 pancrelipase MT 21 capsules containing a total of 63 000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus. |
| 002 | ACTIVE_COMPARATOR | Ensure Plus A high-fat liquid meal of 500 ml of Ensure Plus |
| Name | Type | Description |
|---|---|---|
| Ensure Plus | DIETARY_SUPPLEMENT | A high-fat liquid meal of 500 ml of Ensure Plus |
| Pancrelipase in combination with Ensure Plus | DRUG | 3 pancrelipase MT 21 capsules containing a total of 63,000 USP units of lipase with a high-fat liquid meal of 500 ml of Ensure Plus. |
Inclusion Criteria: * Must have evidence of chronic pancreatitis or pancreatic insufficiency (steatorrhea) confirmed prior to screening * Must be able to discontinue treatment with any pancreatic enzyme preparations (PEPs) within 72 hours before admission to the study center for the open-label phas...
Pancrelipase in combination with Ensure Plus is being studied for exocrine pancreatic insufficiency, a condition in which the pancreas does not produce enough digestive enzymes. The completed Phase 1 study enrolled patients with severe exocrine pancreatic insufficiency, including those with chronic pancreatitis and steatorrhea. It is a gastrointestinal-focused investigational approach.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of pancrelipase in combination with Ensure Plus. The program sits within the company's gastrointestinal therapeutic area and has been evaluated in a single completed clinical study in patients with exocrine pancreatic insufficiency.
Pancrelipase in combination with Ensure Plus is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 13 patients and was not randomized or double blinded, using an active-controlled design.
The trial is NCT00676702, titled A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI). It was a completed Phase 1 study with 13 enrolled patients, an active-controlled design, and no randomization or blinding. Participants were adults 18 years and older.
NCT00676702 evaluated enzyme activity and safety of pancrelipase in patients with severe exocrine pancreatic insufficiency. The completed Phase 1 study enrolled 13 adults and included patients with chronic pancreatitis, steatorrhea, and pancreatitis. It was active controlled, not randomized, and not double blinded, and it did not use biomarker selection.