Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs

NCT01228643 | Withdrawn Phase 3

• 1 other identifier: PANBER0607
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 16 patients of both sexes aged 14 to 65 years, patients with pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay Farma Ltda.

Conditions

Chronic Renal Failure

Keywords

Pancreatic enzymes.; To evaluate the efficacy of drugs in chronic renal failure

Outcome Measures

Primary Outcomes (1)

• Balance of fat in feces.

  06 weeks of treatment.

Secondary Outcomes (1)

• Prove the efficacy of pancreatic enzyme Norzyme ® through the activity of lipase in the formulation contained in the control of steatorrhea

  06 weeks of treatment.

Study Arms (2)

Norzyme®

EXPERIMENTAL

Biological: Pancreatic enzimes

Creon®

ACTIVE COMPARATOR

Device: Creon ®

Interventions

Pancreatic enzimes BIOLOGICAL

\- Norzyme ® (product testing) composition: 20.000USP lipase, 65.000USP of 65.000USP amylase and protease.

Norzyme®

Creon ® DEVICE

\- Creon ® (reference product) composition: 25.000UI lipase, amylase 74.700UI 62.500UI and protease

Creon®

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento LTDA

Valinhos, São Paulo, 13271000, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre Frederico, Doctor

  LAL Clinical Reseach e Development Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Alexandre Frederico

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: October 26, 2010
• Study Start: June 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BR (1)