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

Study Overview
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Brief Summary
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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.

Detailed Description
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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
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Pancreatic Insufficiency

Intervention / Treatment
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* Dietary Supplement: Norzyme - Bergamo
* Dietary Supplement: Creon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must agree with the purposes of the study and sign the Informed Consent in two ways; Be aged over 18 years; Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease; Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals; Agree to record daily food intake in phase 2 and repeat the diet in phase 3; Present ability to meet the patient's diary; Be clinically compensated with replacement therapy; Must be admitted patients in both the sexes; Must be accepted patients of any ethnicity. Exclusion Criteria: Cystic fibrosis; Acute pancreatitis; Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study; Diabetes decompensated; Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study; Any type of treatment for morbid obesity; Abusive use of alcohol in the three months preceding the study; Pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norzyme<br>Pancreatic Enzymes - Norzyme (Bergamo) | Dietary Supplement: Norzyme - Bergamo<br>* 2 - 8 tablets per day.<br>|
| Active Comparator: Creon (Solvay)<br>Pancreatic Enzymes - Creon (Solvay) | Dietary Supplement: Creon<br>* 2 - 8 tablets pet day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |