Chronic Diarrhea

Moustafa Abd Ellatif

Epidemiology of Chronic Diarrhea Among Children Admitted to Gastroenterology Unit at Assuit University Children Hospital

Not yet recruiting: Participants are not yet being recruited

moustafa abd ellatif

director clinical research

Assiut University

Pancrease MT 10.5 or MT 21 Pancrease MT capsules for maximum dose of 10 000 lipase units / Kg / day

Placebo for Pancrease MT 10.5 or MT 21 Capsules with Pancrease MT excipients without the active enzymes

Matching placebo capsules taken by mouth per meal or snack

Placebo

Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack

PANCREASE MT

Total

Sex: Female, Male

Race (NIH/OMB)

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.

Change in the Coefficient of Fat Absorption (COA-fat Percent)

The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase

Change in Percent COA-Protein (Nitrogen)

Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase.

Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase

Overall Study

Director, Clinical Team Leader

Exocrine Pancreatic Insufficiency

Steatorrhea

Malabsorption Syndromes

Cystic Fibrosis

Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day

Pancrease MT 10.5, or MT 21

Capsules with Pancrease MT excipients without the active enzymes

Placebo for Pancrease MT 10.5 or MT 21

A randomized double-blind (withdrawal) Phase 3 study to evaluate the efficacy and tolerability of PANCREASE MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency

A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

steatorrhea/nausea

Epidemiology of Chronic Diarrhea Among Children Admitted to Gastroenterology Unit at Assuit University Children Hospital

A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

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