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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137382

Enrollment

Registered

2014-05-13

Start date

2014-01-31

Completion date

2014-08-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Interventions

DRUGCreon®

active comparator

DRUGCreon N

experimental drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Total Fat Excretion	5 days	Total amount of fat excreted during the stool collection period in grams.
Stool Frequency	5 days	Stool frequency is the average of the daily number of stools recorded during the treatment period
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)
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).
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).

Countries

Hungary, Spain

Participant flow

Recruitment details

50 patients consented, between January and March 2014.

Pre-assignment details

41 of the 50 patients who consented were randomized; the 9 patients who were not randomized were screening failures.

Participants by arm

Arm	Count
Sequence Creon N/Creon® or Creon®/Creon N Participants who were randomized to receive either Creon N or Creon.	41
Total	41

Baseline characteristics

Characteristic	Sequence Creon N/Creon® or Creon®/Creon N
Age, Categorical <=18 years	13 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	28 Participants
Age, Continuous	23.5 years STANDARD_DEVIATION 8
Region of Enrollment Hungary	15 Participants
Region of Enrollment Spain	26 Participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	9 / 39	6 / 41
serious Total, serious adverse events	0 / 39	0 / 41

Arm	Measure	Value (MEAN)	Dispersion
Creon®	Total Fat Excretion	48.1 Grams	Standard Deviation 43.28
Creon N	Total Fat Excretion	42.3 Grams	Standard Deviation 27.05

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Coefficient of Fat Absorption (CFA)

Coefficient of Nitrogen Absorption (CNA).

Percentage of Days With Formed/Normal Stools

Percentage of Days With no Abdominal Pain

Percentage of Days With no Flatulence

Stool Frequency

Total Fat Excretion