Trial · NCT01747330

Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

NCT01747330, Phase 3, Completed, Abbott Products; results first posted 2014-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency. Trials, record NCT01747330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01747330

On this page

Trial

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

Title: Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
NCT number: NCT01747330
Status: Completed
Phases: Phase 3
Enrollment: 40 participants, actual
Lead sponsor: Abbott Products
Conditions: Pancreatic Exocrine Insufficiency
Interventions: Pancreatin
First posted: 2012-12-11
Last updated: 2014-07-15
Results first posted: 2014-07-15

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Body Weight	3 months	change from baseline at day 84
Primary	Height	3 months	change from baseline at day 84
Primary	Stool Frequency	3 months	Average daily stool frequency during treatment period: Number of bowel movements per day
Primary	Stool Consistency	3 months	Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
Primary	Subject's Acceptance of Treatment	3 months	Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.
Secondary	Number of Subjects With Adverse Events	4 months
Secondary	Pulse	3 months	Change from Baseline at Day 84
Secondary	Number of Participants With Findings During Physical Examination	3 months	A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.
Secondary	Number of Participants With Clinical Relevant Safety Laboratory Values	3 months	(hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Body Weight	3 months	Full Analysis subject sample	kg	MEAN
PRIMARY	Height	3 months	Full Analysis subject sample	m	MEAN
PRIMARY	Stool Frequency	3 months	Full Analysis subject sample	Bowel movements per day	MEAN
PRIMARY	Stool Consistency	3 months	Full Analysis subject sample	% of days with normal stool consistency	MEAN
PRIMARY	Subject's Acceptance of Treatment	3 months	Full Analysis subject sample	percentage of participants	NUMBER
SECONDARY	Number of Subjects With Adverse Events	4 months	Full Analysis subject sample	participants	NUMBER
SECONDARY	Pulse	3 months		bpm	MEAN
SECONDARY	Number of Participants With Findings During Physical Examination	3 months	Full Analysis subject sample	participants	NUMBER
SECONDARY	Number of Participants With Clinical Relevant Safety Laboratory Values	3 months	Full Analysis subject sample	participants	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Body Weight	Creon Micro, Minimicrospheres		0.75	Standard Deviation 0.61	kg
Height	Creon Micro, Minimicrospheres		0.026	Standard Deviation 0.020	m
Stool Frequency	Creon Micro, Minimicrospheres		2.1	Standard Deviation 0.8	Bowel movements per day
Stool Consistency	Creon Micro, Minimicrospheres		55.4	Standard Deviation 26.4	% of days with normal stool consistency
Subject's Acceptance of Treatment	Creon Micro, Minimicrospheres	very good	37.5		percentage of participants
Subject's Acceptance of Treatment	Creon Micro, Minimicrospheres	good	52.5		percentage of participants
Subject's Acceptance of Treatment	Creon Micro, Minimicrospheres	moderate	10.0		percentage of participants
Subject's Acceptance of Treatment	Creon Micro, Minimicrospheres	unsatisfactory	0		percentage of participants
Number of Subjects With Adverse Events	Creon Micro, Minimicrospheres		16		participants
Pulse	Creon Micro, Minimicrospheres		-3.1	Standard Deviation 9.4	bpm

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Creon Micro, Minimicrospheres	40
Overall Study	COMPLETED	Creon Micro, Minimicrospheres	40
Overall Study	NOT COMPLETED	Creon Micro, Minimicrospheres	0

Source ClinicalTrials.gov

Adverse events3

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	infections NEC	Infections and infestations	Creon Micro, Minimicrospheres	6	40	8
other	upper respiratory tract infections	Infections and infestations	Creon Micro, Minimicrospheres	3	40	4
other	gastrointestinal spastic and hypermotility disorders	Gastrointestinal disorders	Creon Micro, Minimicrospheres	3	40	3

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Creon Micro, Minimicrospheres
Total, other adverse events	Creon Micro, Minimicrospheres	12	40
Total, serious adverse events	Creon Micro, Minimicrospheres	0	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25066363	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 comparisons0

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

None in this release.

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/NCT01747330

GET https://conductscience.org/api/trials/v1/NCT01747330/registered

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