NCT01747330

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2012

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

November 23, 2012

Results QC Date

December 23, 2013

Last Update Submit

June 13, 2014

Conditions

Pancreatic Exocrine Insufficiency

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (5)

  • Body Weight

    change from baseline at day 84

    3 months

  • Height

    change from baseline at day 84

    3 months

  • Stool Frequency

    Average daily stool frequency during treatment period: Number of bowel movements per day

    3 months

  • Stool Consistency

    Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery

    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.

    3 months

Secondary Outcomes (4)

  • Number of Subjects With Adverse Events

    4 months

  • Pulse

    3 months

  • Number of Participants With Findings During Physical Examination

    3 months

  • Number of Participants With Clinical Relevant Safety Laboratory Values

    3 months

Study Arms (1)

Creon micro, minimicrospheres

EXPERIMENTAL
Drug: Pancreatin

Interventions

PancreatinDRUG

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

Also known as: Creon micro
Creon micro, minimicrospheres

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Site Reference ID/Investigator# 80716

Barnaul, 656019, Russia

Location

Site Reference ID/Investigator# 80693

Moscow, 117997, Russia

Location

Site Reference ID/Investigator# 80698

Novosibirsk, 630091, Russia

Location

Site Reference ID/Investigator# 80713

Novosibirsk, Russia

Location

Site Reference ID/Investigator# 80715

Orenburg, 460000, Russia

Location

Site Reference ID/Investigator# 80694

Saint Petersburg, 194156, Russia

Location

Site Reference ID/Investigator# 80714

Tomsk, 634050, Russia

Location

Site Reference ID/Investigator# 80697

Voronezh, 394036, Russia

Location

Site Reference ID/Investigator# 80696

Yaroslavl, 150003, Russia

Location

Related Publications (1)

  • 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.

    PMID: 25066363DERIVED

MeSH Terms

Conditions

Exocrine Pancreatic InsufficiencyCystic Fibrosis

Interventions

Pancreatin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

HydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Results Point of Contact

Title
Associate Director Clinical Services
Organization
Abbott
taco.baardman@abbott.com

Study Officials

  • Suntje Sander-Struckmeier, PhD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2012

First Posted

December 11, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 15, 2014

Results First Posted

July 15, 2014

Record last verified: 2014-06

Locations

RU(9)