Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency

Pancreatic Insufficiency Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01012908
• Other study ID #: PANBER0609
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 11, 2009
• Last updated: October 26, 2010
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2009
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Insufficiency

Intervention

Dietary Supplement:
• Norzyme - Bergamo
2 - 8 tablets per day.
• Creon
2 - 8 tablets pet day

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

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