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

NCT02137382, Phase 3, Completed, Abbott; results first posted 2015-11-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02137382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02137382

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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
NCT number: NCT02137382
Status: Completed
Phases: Phase 3
Enrollment: 41 participants, actual
Lead sponsor: Abbott
Conditions: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Interventions: Creon®, Creon N
First posted: 2014-05-13
Last updated: 2016-01-22
Other registries' IDs: eudract:2013-002819-10
Results first posted: 2015-11-27

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Coefficient of Fat Absorption (CFA)	5 days	Per protocol	percentage of fat intake	MEAN
SECONDARY	Coefficient of Nitrogen Absorption (CNA).	5 days	Per protocol	percentage of nitrogen intake	MEAN
SECONDARY	Total Fat Excretion	5 days	Per protocol	Grams	MEAN
SECONDARY	Stool Frequency	5 days	Per protocol	number of stools per day	MEAN
SECONDARY	Percentage of Days With no Flatulence	5 days	Per protocol	percentage of days	MEAN
SECONDARY	Percentage of Days With no Abdominal Pain	5 days	Per protocol	percentage of days	MEAN
SECONDARY	Percentage of Days With Formed/Normal Stools	5 days	Per protocol	percentage of days	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Coefficient of Fat Absorption (CFA)	Creon®	88.1	Standard Deviation 9.23	percentage of fat intake
Coefficient of Fat Absorption (CFA)	Creon N	89.5	Standard Deviation 6.79	percentage of fat intake
Coefficient of Nitrogen Absorption (CNA).	Creon®	87.7	Standard Deviation 5.47	percentage of nitrogen intake
Coefficient of Nitrogen Absorption (CNA).	Creon N	87.8	Standard Deviation 4.68	percentage of nitrogen intake
Total Fat Excretion	Creon®	48.1	Standard Deviation 43.28	Grams
Total Fat Excretion	Creon N	42.3	Standard Deviation 27.05	Grams
Stool Frequency	Creon®	1.57	Standard Deviation 0.6	number of stools per day
Stool Frequency	Creon N	1.49	Standard Deviation 0.6	number of stools per day
Percentage of Days With no Flatulence	Creon®	51.6	Standard Deviation 46.65	percentage of days
Percentage of Days With no Flatulence	Creon N	57.5	Standard Deviation 43.31	percentage of days

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Cross-over Period 1	STARTED	Sequence: Creon N/Creon®	20
Cross-over Period 1	STARTED	Sequence: Creon®/Creon N	21
Cross-over Period 1	COMPLETED	Sequence: Creon N/Creon®	18
Cross-over Period 1	COMPLETED	Sequence: Creon®/Creon N	21
Cross-over Period 1	NOT COMPLETED	Sequence: Creon N/Creon®	2
Cross-over Period 1	NOT COMPLETED	Sequence: Creon®/Creon N	0
Wash Out	STARTED	Sequence: Creon N/Creon®	18
Wash Out	STARTED	Sequence: Creon®/Creon N	21
Wash Out	COMPLETED	Sequence: Creon N/Creon®	18
Wash Out	COMPLETED	Sequence: Creon®/Creon N	21

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Flatulence	Gastrointestinal disorders	Creon®	3	39	3
other	Flatulence	Gastrointestinal disorders	Creon N	0	41	0
other	Headache	Nervous system disorders	Creon®	2	39	2
other	Headache	Nervous system disorders	Creon N	0	41	0
other	Abdominal pain	Gastrointestinal disorders	Creon®	1	39	1
other	Abdominal pain	Gastrointestinal disorders	Creon N	1	41	1
other	Abdominal pain	Gastrointestinal disorders	Creon®	1	39	1
other	Abdominal pain	Gastrointestinal disorders	Creon N	0	41	0
other	Abdominal pain lower	Gastrointestinal disorders	Creon®	0	39	0
other	Abdominal pain lower	Gastrointestinal disorders	Creon N	1	41	1

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Creon®
Total, all-cause mortality	Creon N
Total, other adverse events	Creon®	9	39
Total, other adverse events	Creon N	6	41
Total, serious adverse events	Creon®	0	39
Total, serious adverse events	Creon N	0	41

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32761612	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Creon® vs Creon N: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02137382

GET https://conductscience.org/api/trials/v1/NCT02137382/events?page=2

API reference For AI assistants