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

Azidus

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Pancreatic Insufficiency

Treatments

Dietary Supplement: Norzyme - Bergamo

Dietary Supplement: Creon

Study type

Interventional

Funder types

Industry

Identifiers

NCT01012908

PANBER0609

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.