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

NCT01012908 | Unknown Phase 2 DMC

• 1 other identifier: PANBER0609
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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)

Study Arms (2)

Norzyme

EXPERIMENTAL

Pancreatic Enzymes - Norzyme (Bergamo)

Dietary Supplement: Norzyme - Bergamo

Creon (Solvay)

ACTIVE COMPARATOR

Pancreatic Enzymes - Creon (Solvay)

Dietary Supplement: Creon

Interventions

Norzyme - Bergamo DIETARY_SUPPLEMENT

2 - 8 tablets per day.

Norzyme

Creon DIETARY_SUPPLEMENT

2 - 8 tablets pet day

Creon (Solvay)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: March 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2011
• Last Updated: October 28, 2010

Record last verified: 2009-11

Locations

BR (1)