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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:
- Incidence of abdominal pain;
- Frequency of flatus;
- Frequency of bowel movements during the treatment;
- Consistency of stools during treatment;
- Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Norzyme - Bergamo, Creon
Lal Clinica Pesquisa E Desenvolvimento Ltda
Not yet recruiting
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Published on BioPortfolio: 2014-08-27T03:18:02-0400
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