Pancreatic Exocrine InsufficiencyPhase 3NCT01747330

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

A Phase 3 study testing Pancreatin in people with Pancreatic Exocrine Insufficiency, run by Abbott Products at 9 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency. Read more about this study

Who is it for?: Ages Up to 4 years
Conditions the study is for: Pancreatic Exocrine Insufficiency
What is being tested?: Pancreatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 9 sitesRussia
Study dates: Jun 2012to Dec 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms

Who cannot join

Ileus or acute abdomen
history of fibrosing colonopathy
history of distal ileal obstruction without surgery
solid organ transplant or surgery affecting the large bowel, other than appendectomy

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Russia9 sites

Site Reference ID/Investigator# 80716
Barnaul, 656019
Site Reference ID/Investigator# 80693
Moscow, 117997
Site Reference ID/Investigator# 80698
Novosibirsk, 630091
Site Reference ID/Investigator# 80713
Novosibirsk
Site Reference ID/Investigator# 80715
Orenburg, 460000
Site Reference ID/Investigator# 80694
Saint Petersburg, 194156
Site Reference ID/Investigator# 80714
Tomsk, 634050
Site Reference ID/Investigator# 80697
Voronezh, 394036
Site Reference ID/Investigator# 80696
Yaroslavl, 150003

Other trials in Russia

About this study

Official title: An Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

Read the detailed description

A prospective open-label, multi-center study evaluating safety and tolerability of Creon Micro in pediatric subjects from at least one month to less than four years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis (CF). Referring to the European Medicines Agency (EMEA) pediatric age criteria for the purpose of the study, subjects are categorized as infants and toddlers (< 2 years) and children, (2 years to < 4 years). In total, 40 subjects will be enrolled (20 subjects in each age subgroup). Subjects receive their prescribed pancreatic enzyme supplementation at the individual dose until start of treatment with Creon Micro, if the subjects were on pancreatic enzyme supplementation before start of the study. Subjects will be treated with Creon Micro during the study. The treatment duration is 3 months.

Conditions: Pancreatic Exocrine Insufficiency
Being tested: Pancreatin
Keywords: cystic fibrosis
Medical subject headings: Exocrine Pancreatic Insufficiency, Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PancreatinDrug
Also called Creon micro
Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used

Study groups in NCT01747330
Study group	Role	What they receive
Creon micro, minimicrospheres	Experimental	Not described Receives: Drug: Pancreatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight
change from baseline at day 84
Measured: 3 months
Height
change from baseline at day 84
Measured: 3 months
Stool Frequency
Average daily stool frequency during treatment period: Number of bowel movements per day
Measured: 3 months
Stool Consistency
Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
Measured: 3 months
Subject's Acceptance of Treatment
Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.
Measured: 3 months

Secondary outcomes (4)

Number of Subjects With Adverse Events
Measured: 4 months
Pulse
Change from Baseline at Day 84
Measured: 3 months
Number of Participants With Findings During Physical Examination
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.
Measured: 3 months
Number of Participants With Clinical Relevant Safety Laboratory Values
(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)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2012

First posted11 Dec 2012 (estimated)
Study startJun 2012
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreatic Exocrine InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01747330
Sponsor's protocol ID: M13-277
Status last verified: Jun 2014
First submitted: 23 Nov 2012
Last updated: 15 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kashirskaya NY, Kapranov NI, Sander-Struckmeier S, Kovalev V. Safety and efficacy of Creon(R) micro in children with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2015 Mar;14(2):275-81. doi: 10.1016/j.jcf.2014.07.006. Epub 2014 Jul 25.
PubMed 25066363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pancreatic Exocrine Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
ClinicalTrials.gov ID: NCT01747330
Acronym / sponsor ID: M13-277
Conditions: Pancreatic Exocrine Insufficiency
Keywords: cystic fibrosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Abbott ProductsIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 11 Dec 2012 (estimated)
Results: Posted 15 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Creon micro, minimicrospheres	Experimental	Drug: Pancreatin

Who may qualify

Ages: Up to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms

Key exclusion criteria (4 listed)

Ileus or acute abdomen
history of fibrosing colonopathy
history of distal ileal obstruction without surgery
solid organ transplant or surgery affecting the large bowel, other than appendectomy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PancreatinAlso: Creon microDoses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used	Drug	Creon micro, minimicrospheres

Primary outcome

Body Weight
Time frame: 3 months
change from baseline at day 84
Height
Time frame: 3 months
change from baseline at day 84
Stool Frequency
Time frame: 3 months
Average daily stool frequency during treatment period: Number of bowel movements per day
Stool Consistency
Time frame: 3 months
Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
Subject's Acceptance of Treatment
Time frame: 3 months
Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.

4 secondary outcomes

Number of Subjects With Adverse Events
Time frame: 4 months
Pulse
Time frame: 3 months
Number of Participants With Findings During Physical Examination
Time frame: 3 months
Number of Participants With Clinical Relevant Safety Laboratory Values
Time frame: 3 months

Results and safety

Results posted to the registry on 15 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Creon Micro, Minimicrospheres	40	40

Primary outcome: Body Weight

Time frame: 3 months. Mean (Standard Deviation). Unit: kg

Measure	Creon Micro, Minimicrospheres n = 40
Value	0.75 (0.61)

Population analysed: Full Analysis subject sample

Primary outcome: Height

Time frame: 3 months. Mean (Standard Deviation). Unit: m

Measure	Creon Micro, Minimicrospheres n = 40
Value	0.026 (0.020)

Population analysed: Full Analysis subject sample

Primary outcome: Stool Frequency

Time frame: 3 months. Mean (Standard Deviation). Unit: Bowel movements per day

Measure	Creon Micro, Minimicrospheres n = 40
Value	2.1 (0.8)

Population analysed: Full Analysis subject sample

Primary outcome: Stool Consistency

Time frame: 3 months. Mean (Standard Deviation). Unit: % of days with normal stool consistency

Measure	Creon Micro, Minimicrospheres n = 40
Value	55.4 (26.4)

Population analysed: Full Analysis subject sample

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Creon Micro, Minimicrospheres	0 of 40 (0%)	12 of 40 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25066363Kashirskaya NY, Kapranov NI, Sander-Struckmeier S, Kovalev V. Safety and efficacy of Creon(R) micro in children with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2015 Mar;14(2):275-81. doi: 10.1016/j.jcf.2014.07.006. Epub 2014 Jul 25.

Related trials for Pancreatic Exocrine Insufficiency

RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suntje Sander-Struckmeier, PhD study director

Abbott

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pancreatin in people with Pancreatic Exocrine Insufficiency, run by Abbott Products at 9 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01747330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.