Safety and Maintenance Study of Entocort for Children With Crohn's Disease

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01453946
• Collaborator: (none)
• Enrollment: 55
• Locations: 19
• Arm: 1
• Duration (Months): 26.1
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: Entocort	Phase 3

Detailed Description

A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Entocort Study Medication	Drug: Entocort; Entocort capsules, taken orally, 6 mg daily.

Outcome Measures

Primary Outcome Measures

1. Adverse Event [16 weeks]

   Any kind of adverse event

Secondary Outcome Measures

1. PCDAI [12 weeks]

   Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)

2. IMPACT 3 [12 weeks]

   IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Atlanta	Georgia	United States
2	Research Site	Oak Lawn	Illinois	United States
3	Research Site	Newton	Massachusetts	United States
4	Research Site	Saint Paul	Minnesota	United States
5	Research Site	Mays Landing	New Jersey	United States
6	Research Site	Buffalo	New York	United States
7	Research Site	Houston	Texas	United States
8	Research Site	Halifax	Nova Scotia	Canada
9	Research Site	London	Ontario	Canada
10	Research Site	München		Germany
11	Research Site	Nürnberg		Germany
12	Research Site	Firenze		Italy
13	Research Site	Messina		Italy
14	Research Site	Roma		Italy
15	Research Site	Kraków		Poland
16	Research Site	Rzeszów		Poland
17	Research Site	Warszawa		Poland
18	Research Site	Wrocław		Poland
19	Research Site	Łódź		Poland

Sponsors and Collaborators

• Padagis LLC

Investigators

• Principal Investigator: Stanley Cohen, MD, Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA
• Study Director: Stefan Eklund, MD, AstraZeneca Pharmaceuticals, Mölndal, Sweden

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CSR Synopsis

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT01453946
• Other Study ID Numbers: D9422C00002
• First Posted: Oct 18, 2011
• Last Update Posted: Jan 6, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Padagis LLC: Crohn's Disease
• Additional relevant MeSH terms: Crohn Disease; Budesonide

Study Results

Participant Flow

Recruitment Details	In this study, 55 patients were enrolled but only 50 fulfilled the enrolment criteria.
Pre-assignment Detail	55 patients were enrolled but only 50 received treatment.

Arm/Group Title	Entocort
Arm/Group Description	Entocort 6 mg/day
Period Title: Overall Study
STARTED	50
COMPLETED	41
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Entocort
Arm/Group Description	Entocort 6 mg/day
Overall Participants	50
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	13.8
Age, Customized (participants) [Number]
<=8 years	2 4%
>8 years	48 96%
Sex: Female, Male (Count of Participants)
Female	20 40%
Male	30 60%
Race/Ethnicity, Customized (participants) [Number]
White	45 90%
Black or african american	2 4%
Other	3 6%

Outcome Measures

1. Secondary Outcome

Title	PCDAI
Description	Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Entocort
Arm/Group Description	Entocort 6 mg/day
Measure Participants	49
Baseline	4.9 (3.6)
Change after 12 weeks	2.0 (7.0)
12 weeks	6.9 (8.1)

2. Secondary Outcome

Title	IMPACT 3
Description	IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Entocort
Arm/Group Description	Entocort 6 mg/day
Measure Participants	50
Baseline	146.6 (12.4)
Change after 12 weeks	1.2 (8.6)
12 weeks	147.0 (15.5)

3. Primary Outcome

Title	Adverse Event
Description	Any kind of adverse event
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Entocort
Arm/Group Description	Entocort 6 mg/day
Measure Participants	50
Number [Subjects]	37

Adverse Events

Time Frame	16 weeks
Adverse Event Reporting Description	12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Arm/Group Title	Entocort
Arm/Group Description	Entocort 6 mg/day
All Cause Mortality
	Entocort
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Entocort
	Affected / at Risk (%)	# Events
Total	4/50 (8%)
Gastrointestinal disorders
Crohn's disease	3/50 (6%)	3
Gastrointestinal haemhorrage	1/50 (2%)	1
Ileal stenosis	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Entocort
	Affected / at Risk (%)	# Events
Total	36/50 (72%)
Endocrine disorders
Cushingoid	4/50 (8%)
Gastrointestinal disorders
Abdominal pain	8/50 (16%)
Crohn's disease	4/50 (8%)
Dyspepsia	3/50 (6%)
Diarrhoea	2/50 (4%)
Haematochizia	2/50 (4%)
Vomiting	2/50 (4%)
General disorders
Irritability	4/50 (8%)
Infections and infestations
Nasopharyngitis	3/50 (6%)
Upper respiratory tract infection	3/50 (6%)
Gastroenteritis	2/50 (4%)
Gastroenteritis viral	2/50 (4%)
Metabolism and nutrition disorders
Increased appetite	4/50 (8%)
Decreased appetite	3/50 (6%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/50 (6%)
Pain in extremity	2/50 (4%)
Nervous system disorders
Headache	2/50 (4%)
Psychiatric disorders
Mood swings	4/50 (8%)
Skin and subcutaneous tissue disorders
Acne	6/50 (12%)
Hirsutism	2/50 (4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.