NCT01453946

Brief Summary

A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Geographic Reach
5 countries

19 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

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 19, 2015

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

October 14, 2011

Results QC Date

February 11, 2015

Last Update Submit

January 4, 2022

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Any kind of adverse event

    16 weeks

Secondary Outcomes (2)

  • PCDAI

    12 weeks

  • IMPACT 3

    12 weeks

Study Arms (1)

Entocort

OTHER

Study Medication

Drug: Entocort

Interventions

EntocortDRUG

Entocort capsules, taken orally, 6 mg daily.

Entocort

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
  • All subjects must weight \>= 15 kg at the time of enrollment.
  • Subjects must have been diagnosed and treated for active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology and have a PCDAI \<= 10

You may not qualify if:

  • Subjects who have had any previous intestinal resection proximal to and including the ascending colon.
  • Subjects with evidence of active Crohn's disease (PCDAI \> 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications.
  • Subjects with morning cortisol level \<150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Atlanta, Georgia, United States

Location

Research Site

Oak Lawn, Illinois, United States

Location

Research Site

Newton, Massachusetts, United States

Location

Research Site

Saint Paul, Minnesota, United States

Location

Research Site

Mays Landing, New Jersey, United States

Location

Research Site

Buffalo, New York, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

München, Germany

Location

Research Site

Nuremberg, Germany

Location

Research Site

Florence, Italy

Location

Research Site

Messina, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Rzeszów, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Wroclaw, Poland

Location

Related Publications (1)

  • Cohen SA, Aloi M, Arumugam R, Baker R, Bax K, Kierkus J, Koletzko S, Lionetti P, Persson T, Eklund S. Enteric-coated budesonide for the induction and maintenance of remission of Crohn's disease in children. Curr Med Res Opin. 2017 Jul;33(7):1261-1268. doi: 10.1080/03007995.2017.1313213. Epub 2017 Apr 19.

    PMID: 28420280DERIVED

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Beatriz North
Organization
Perrigo
beatriz.north@perrigo.com
718-960-0163

Study Officials

  • Stanley Cohen, MD

    Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA

    PRINCIPAL INVESTIGATOR

  • Stefan Eklund, MD

    AstraZeneca Pharmaceuticals, Mölndal, Sweden

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 6, 2022

Results First Posted

June 19, 2015

Record last verified: 2022-01

Locations

DE(2)CA(2)US(7)IT(3)PL(5)