Clinical trial NCT02137382: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Keywords: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Coefficient of Fat Absorption (CFA)
timeFrame: 5 days
Secondary outcomes:
measure: Coefficient of Nitrogen Absorption (CNA).
timeFrame: 5 days
measure: Total Fat Excretion
timeFrame: 5 days
measure: Stool Frequency
timeFrame: 5 days
measure: Percentage of Days With no Flatulence
timeFrame: 5 days
measure: Percentage of Days With no Abdominal Pain
timeFrame: 5 days
measure: Percentage of Days With Formed/Normal Stools
timeFrame: 5 days
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Research facility ID ORG-000826
city: Debrecen
country: Hungary
facility: Research facility ID ORG-000816
city: Kaposvár
country: Hungary
facility: Research facility ID ORG-000827
city: Törökbálint
country: Hungary
facility: Research facility ID ORG-000825
city: Barcelona
country: Spain
facility: Research facility ID ORG-000829
city: Sevilla
country: Spain
facility: Research facility ID ORG-000828
city: Valencia
country: Spain
facility: Research facility ID ORG-000815
Study officials:
affiliation: Abbott
name: Suntje Sander-Struckmeier, PhD
role: STUDY_DIRECTOR
References:
citation: Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.