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

Sponsor
Azidus Brasil (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01012908
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
15
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Apr 1, 2010
Anticipated Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Amount of fat in the stools of 72 hours of medication use between the two treatments. [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 [First period: days 1 - 14. Second period: days 1-14. (every day)]

  2. Consistency and characteristics of feces [First period: days 1 - 14. Second period: days 1-14. (every day)]

  3. Frequency and intensity of abdominal pain daily [First period: days 1 - 14. Second period: days 1-14. (every day)]

  4. Frequency of flatulence daily [First period: days 1 - 14. Second period: days 1-14. (every day)]

  5. Amount of drug used in treatment [First period: days 1 - 14. Second period: days 1-14. (every day)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lal Clinica Pesquisa E Desenvolvimento Ltda Valinhos SP Brazil 13270000

Sponsors and Collaborators

  • Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01012908
Other Study ID Numbers:
  • PANBER0609
First Posted:
Nov 13, 2009
Last Update Posted:
Oct 28, 2010
Last Verified:
Nov 1, 2009
Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency

Study Results

No Results Posted as of Oct 28, 2010