Clinical trial NCT01012908: Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pancreatic Insufficiency
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Amount of fat in the stools of 72 hours of medication use between the two treatments.
timeFrame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day
Secondary outcomes:
measure: Frequency of bowel movements per day
timeFrame: First period: days 1 - 14. Second period: days 1-14. (every day)
measure: Consistency and characteristics of feces
timeFrame: First period: days 1 - 14. Second period: days 1-14. (every day)
measure: Frequency and intensity of abdominal pain daily
timeFrame: First period: days 1 - 14. Second period: days 1-14. (every day)
measure: Frequency of flatulence daily
timeFrame: First period: days 1 - 14. Second period: days 1-14. (every day)
measure: Amount of drug used in treatment
timeFrame: First period: days 1 - 14. Second period: days 1-14. (every day)
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: SP
Study officials:
References: