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Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency

Pancreatic Insufficiency Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01012908
Study type Interventional
Source L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date March 2010
Completion date June 2011
View Details
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