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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 because the information has not been verified recently.
Verified November 2009 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01012908
First received: November 11, 2009
Last updated: October 26, 2010
Last verified: November 2009

November 11, 2009
October 26, 2010
March 2010
April 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01012908 on ClinicalTrials.gov Archive Site
  • Frequency of bowel movements per day [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Consistency and characteristics of feces [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Frequency and intensity of abdominal pain daily [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Frequency of flatulence daily [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Amount of drug used in treatment [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
Not Provided

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Insufficiency
  • Dietary Supplement: Norzyme - Bergamo
    2 - 8 tablets per day.
  • Dietary Supplement: Creon
    2 - 8 tablets pet day
  • Experimental: Norzyme
    Pancreatic Enzymes - Norzyme (Bergamo)
    Intervention: Dietary Supplement: Norzyme - Bergamo
  • Active Comparator: Creon (Solvay)
    Pancreatic Enzymes - Creon (Solvay)
    Intervention: Dietary Supplement: Creon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
June 2011
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01012908
PANBER0609
Yes
Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP