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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Azidus Brasil.
Recruitment status was:  Active, not recruiting
Information provided by:
Azidus Brasil Identifier:
First received: November 11, 2009
Last updated: October 26, 2010
Last verified: November 2009
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.

Condition Intervention Phase
Pancreatic Insufficiency
Dietary Supplement: Norzyme - Bergamo
Dietary Supplement: Creon
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Amount of fat in the stools of 72 hours of medication use between the two treatments. [ Time Frame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day ]

Secondary Outcome Measures:
  • Frequency of bowel movements per day [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ]
  • Consistency and characteristics of feces [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ]
  • Frequency and intensity of abdominal pain daily [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ]
  • Frequency of flatulence daily [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ]
  • Amount of drug used in treatment [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ]

Estimated Enrollment: 25
Study Start Date: March 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norzyme
Pancreatic Enzymes - Norzyme (Bergamo)
Dietary Supplement: Norzyme - Bergamo
2 - 8 tablets per day.
Active Comparator: Creon (Solvay)
Pancreatic Enzymes - Creon (Solvay)
Dietary Supplement: Creon
2 - 8 tablets pet day

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01012908

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT01012908     History of Changes
Other Study ID Numbers: PANBER0609
Study First Received: November 11, 2009
Last Updated: October 26, 2010

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents processed this record on April 28, 2017