NCT01012908

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Insufficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Norzyme - Bergamo	2 - 8 tablets per day.
DIETARY_SUPPLEMENT	Creon	2 - 8 tablets pet day

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-04-01
• Completion: 2011-06-01
• First posted: 2009-11-13
• Last updated: 2010-10-28

Locations

1 site across 1 country: Brazil