Pancreatic Insufficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNorzyme - Bergamo
2 - 8 tablets per day.
DIETARY_SUPPLEMENTCreon
2 - 8 tablets pet day
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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) |
Countries
Brazil
Outcome results
None listed