A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Phase 3

Completed

Conditions: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Interventions: Drug: Creon N
Drug: Creon®

Registration Number: NCT02137382

Lead Sponsor: Abbott

Brief Summary: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
Age ≥ 12 years
Subjects who are able to swallow capsules with each meal and snacks
Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis
Diagnosis of pancreatic exocrine insufficiency proven by:
1. Coefficient of fat absorption (CFA) < 70% without supplementation
2. or Human fecal elastase < 50 μg/g stool
Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
Stable body weight defined as no more than a 5% decline within 3 months of enrolment
Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.

Exclusion Criteria

Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study
History of acute abdomen
History of fibrosing colonopathy
History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment
Solid organ transplant or surgery affecting the large bowel other than appendectomy
Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy)
Pregnancy or lactation
Any type of malignancy involving the digestive tract in the last 5 years
Celiac disease or Crohn's disease
Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules
Suspected non-compliance or non-cooperation
Intake of experimental drugs within 30 days prior to study start
Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study
Diagnosis of human immunodeficiency virus in medical history.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Creon® , then Creon N	Creon N	Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
Creon N, then Creon®	Creon®	Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.

Primary Outcome Measures

Name	Time	Method
Coefficient of Fat Absorption (CFA)	5 days	CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 \[fat intake - fat excretion\] / fat intake

Secondary Outcome Measures

Name	Time	Method
Total Fat Excretion	5 days	Total amount of fat excreted during the stool collection period in grams.
Coefficient of Nitrogen Absorption (CNA).	5 days	CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 \[nitrogen intake - nitrogen excretion\] / nitrogen intake)
Stool Frequency	5 days	Stool frequency is the average of the daily number of stools recorded during the treatment period
Percentage of Days With no Flatulence	5 days	The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\*(number of days with no flatulence/number of days recorded in diary).
Percentage of Days With no Abdominal Pain	5 days	The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\*(number of days with no abdominal pain/ number of days recorded in diary).
Percentage of Days With Formed/Normal Stools	5 days	The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\*(number of days with formed/normal stools/ number of days recorded in diary).

Trial Locations

Locations (7): Research facility ID ORG-000825
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Törökbálint, Hungary
Research facility ID ORG-000816
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Debrecen, Hungary
Research facility ID ORG-000826
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Budapest, Hungary
Research facility ID ORG-000827
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Kaposvár, Hungary
Research facility ID ORG-000829
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Barcelona, Spain
Research facility ID ORG-000828
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Sevilla, Spain
Research facility ID ORG-000815
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Valencia, Spain