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

Primary Purpose

Pancreatic Insufficiency

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Norzyme - Bergamo

Creon

About this trial

This is an interventional treatment trial for Pancreatic Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norzyme

Creon (Solvay)

Arm Description

Pancreatic Enzymes - Norzyme (Bergamo)

Pancreatic Enzymes - Creon (Solvay)

Outcomes

Primary Outcome Measures

Amount of fat in the stools of 72 hours of medication use between the two treatments.

Secondary Outcome Measures

Frequency of bowel movements per day

Consistency and characteristics of feces

Frequency and intensity of abdominal pain daily

Frequency of flatulence daily

Amount of drug used in treatment

Full Information

NCT ID

NCT01012908

First Posted

November 11, 2009

Last Updated

October 26, 2010

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT01012908

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Azidus Brasil

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Norzyme

Arm Type

Experimental

Arm Description

Pancreatic Enzymes - Norzyme (Bergamo)

Arm Title

Creon (Solvay)

Arm Type

Active Comparator

Arm Description

Pancreatic Enzymes - Creon (Solvay)

Intervention Type

Dietary Supplement

Intervention Name(s)

Norzyme - Bergamo

Intervention Description

2 - 8 tablets per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

Creon

Intervention Description

2 - 8 tablets pet day

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Frequency of bowel movements per day

Time Frame