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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 11, 2009
Last Updated Date	October 26, 2010
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 12, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01012908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 12, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
Official Title ^ICMJE	Not Provided
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.
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 ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pancreatic Insufficiency
Intervention ^ICMJE	Dietary Supplement: Norzyme - Bergamo 2 - 8 tablets per day. Dietary Supplement: Creon 2 - 8 tablets pet day
Study Arm (s)	Experimental: Norzyme Pancreatic Enzymes - Norzyme (Bergamo) Intervention: Dietary Supplement: Norzyme - Bergamo Active Comparator: Creon (Solvay) Pancreatic Enzymes - Creon (Solvay) Intervention: Dietary Supplement: Creon
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	25
Estimated Completion Date	June 2011
Estimated Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01012908
Other Study ID Numbers ^ICMJE	PANBER0609
Has Data Monitoring Committee	Yes
Responsible Party	Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
Study Sponsor ^ICMJE	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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