NCT01012908UnknownPhase 2
Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Azidus Brasil
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Amount of fat in the stools of 72 hours of medication use between the two treatments.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Norzyme
Experimental
Pancreatic Enzymes - Norzyme (Bergamo)
Intervention: Norzyme - Bergamo (Dietary Supplement)
Creon (Solvay)
Active Comparator
Pancreatic Enzymes - Creon (Solvay)
Intervention: Creon (Dietary Supplement)
Outcomes
Primary Outcomes
Amount of fat in the stools of 72 hours of medication use between the two treatments.
Time Frame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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