Pancreatic Insufficiency Clinical Trial
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.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | June 2011 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | SP |
Lead Sponsor | Collaborator |
---|---|
L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Frequency of bowel movements per day | First period: days 1 - 14. Second period: days 1-14. (every day) | Yes | |
Secondary | Consistency and characteristics of feces | First period: days 1 - 14. Second period: days 1-14. (every day) | Yes | |
Secondary | Frequency and intensity of abdominal pain daily | First period: days 1 - 14. Second period: days 1-14. (every day) | Yes | |
Secondary | Frequency of flatulence daily | First period: days 1 - 14. Second period: days 1-14. (every day) | Yes | |
Secondary | Amount of drug used in treatment | First period: days 1 - 14. Second period: days 1-14. (every day) | Yes |
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