Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
NCT ID: NCT01012908
Last Updated: 2010-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
25 participants
INTERVENTIONAL
2010-03-31
2011-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Norzyme
Pancreatic Enzymes - Norzyme (Bergamo)
Norzyme - Bergamo
2 - 8 tablets per day.
Creon (Solvay)
Pancreatic Enzymes - Creon (Solvay)
Creon
2 - 8 tablets pet day
Interventions
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Norzyme - Bergamo
2 - 8 tablets per day.
Creon
2 - 8 tablets pet day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Azidus Brasil
INDUSTRY
Responsible Party
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LAL Clinica Pesquisa e Desenvolvimento Ltda
Locations
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Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
Countries
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Other Identifiers
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PANBER0609
Identifier Type: -
Identifier Source: org_study_id