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

Phase 2

• Conditions: Pancreatic Insufficiency
• Interventions: Dietary Supplement: Norzyme - Bergamo; Dietary Supplement: Creon

• Registration Number: NCT01012908
• Lead Sponsor: Azidus Brasil

Brief 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.

Study Timeline

• Status Verified: 2009-11
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Study Start: 2010-03
• Primary Completion: 2010-04
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-28
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Norzyme	Norzyme - Bergamo	Pancreatic Enzymes - Norzyme (Bergamo)
Creon (Solvay)	Creon	Pancreatic Enzymes - Creon (Solvay)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil