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The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.
As a secondary objective will be assessed the following parameters:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norzyme | Experimental | Pancreatic Enzymes - Norzyme (Bergamo) |
|
| Creon (Solvay) | Active Comparator | Pancreatic Enzymes - Creon (Solvay) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norzyme - Bergamo | Dietary Supplement | 2 - 8 tablets per day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of fat in the stools of 72 hours of medication use between the two treatments. | First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of bowel movements per day | First period: days 1 - 14. Second period: days 1-14. (every day) | |
| Consistency and characteristics of feces | First period: days 1 - 14. Second period: days 1-14. (every day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270000 | Brazil |
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| Creon |
| Dietary Supplement |
2 - 8 tablets pet day |
|
| Frequency and intensity of abdominal pain daily | First period: days 1 - 14. Second period: days 1-14. (every day) |
| Frequency of flatulence daily | First period: days 1 - 14. Second period: days 1-14. (every day) |
| Amount of drug used in treatment | First period: days 1 - 14. Second period: days 1-14. (every day) |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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