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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Insufficiency
• Intervention / Treatment: Dietary supplement: Norzyme - Bergamo; Dietary supplement: Creon

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norzyme; Pancreatic Enzymes - Norzyme (Bergamo)	Dietary supplement: Norzyme - Bergamo; 2 - 8 tablets per day.
Active Comparator: Creon (Solvay); Pancreatic Enzymes - Creon (Solvay)	Dietary supplement: Creon; 2 - 8 tablets pet day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: November 11, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 26, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: PANBER0609