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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

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ClinicalTrials.gov Identifier: NCT02137382
Recruitment Status : Completed
First Posted : May 13, 2014
Results First Posted : November 27, 2015
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott

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

Condition or disease Intervention/treatment Phase
Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Drug: Creon® Drug: Creon N Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Creon N, then 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.
Drug: Creon®
active comparator

Experimental: Creon® , then 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.
Drug: Creon N
experimental drug




Primary Outcome Measures :
  1. Coefficient of Fat Absorption (CFA) [ Time Frame: 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 :
  1. Coefficient of Nitrogen Absorption (CNA). [ Time Frame: 5 days ]
    CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)

  2. Total Fat Excretion [ Time Frame: 5 days ]
    Total amount of fat excreted during the stool collection period in grams.

  3. Stool Frequency [ Time Frame: 5 days ]
    Stool frequency is the average of the daily number of stools recorded during the treatment period

  4. Percentage of Days With no Flatulence [ Time Frame: 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).

  5. Percentage of Days With no Abdominal Pain [ Time Frame: 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).

  6. Percentage of Days With Formed/Normal Stools [ Time Frame: 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).



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137382


Locations
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Hungary
Research facility ID ORG-000826
Budapest, Hungary, 1122
Research facility ID ORG-000816
Debrecen, Hungary, 4031
Research facility ID ORG-000827
Kaposvár, Hungary, 7400
Research facility ID ORG-000825
Törökbálint, Hungary, 2045
Spain
Research facility ID ORG-000829
Barcelona, Spain, 8035
Research facility ID ORG-000828
Sevilla, Spain, 41013
Research facility ID ORG-000815
Valencia, Spain, 46026
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Suntje Sander-Struckmeier, PhD Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02137382    
Other Study ID Numbers: PANC3004
2013-002819-10 ( EudraCT Number )
First Posted: May 13, 2014    Key Record Dates
Results First Posted: November 27, 2015
Last Update Posted: January 22, 2016
Last Verified: January 2016
Keywords provided by Abbott:
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents