Status:
WITHDRAWN
Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs
Lead Sponsor:
Azidus Brasil
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
Brief Summary
Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in controlling steatorrhea in 1...
Detailed Description
Phase III clinical trial systematic sampling, double-blind, randomized, crossed that evaluates the comparative efficacy of a formulation containing enzyme pancreas in 16 patients with pancreatic insuf...
Eligibility Criteria
Inclusion
- nclusion Criteria:
- Research subjects aged between 14 and 65 years of both sexes;
- Exogenous pancreatic insufficiency of any etiology;
- Subjects who do not regularly use or pancreatic enzymes by orally;
- Freely agree to sign the consent form and clarified before all the essential elements of the protocol be clarified before any procedure.
- Exclusion Criteria:
- Participation in any study or have ingested some experimental drug trial in the 3 months preceding the study.
- Regular use of medication that interferes with the action of the drug test:
- in the 4 weeks preceding the study or make use of any medications that interfere with drug test a week before the start the study.
- Patients who take any kind of treatment for morbid obesity.
- Cases of stomach reduction surgery.
- Cases of surgical reduction of the intestine.
- Present history of current abuse of alcohol or have drunk alcohol in the 48 hours prior to the study.
- Have any condition which prevents him from participating in the study, for trial Principal Investigator.
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01228643
Start Date
June 1 2007
End Date
December 1 2011
Last Update
November 3 2022
Active Locations (1)
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1
LAL Clinica Pesquisa e Desenvolvimento LTDA
Valinhos, São Paulo, Brazil, 13271000