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

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ClinicalTrials.gov Identifier: NCT01012908
Recruitment Status : Unknown
Verified November 2009 by Azidus Brasil.
Recruitment status was:  Active, not recruiting
First Posted : November 13, 2009
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
Azidus Brasil

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.

Condition or disease Intervention/treatment Phase
Pancreatic Insufficiency Dietary Supplement: Norzyme - Bergamo Dietary Supplement: Creon Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012908


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

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01012908     History of Changes
Other Study ID Numbers: PANBER0609
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: November 2009

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents