Safety Study of Entocort for Children With Crohn's Disease

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01444092
• Collaborator: (none)
• Enrollment: 123
• Locations: 24
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A Safety Study using 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 for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 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 for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Entocort Study Medication	Drug: Entocort; Entocort capsules, oral

Outcome Measures

Primary Outcome Measures

1. Adverse Event [12 weeks]

   Number of patients with at least one adverse event

Secondary Outcome Measures

1. PCDAI [Baseline to 8 weeks]

   Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).

2. IMPACT 3 [Baseline to 8 weeks]

   IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).

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.

• Subject must be diagnosed with 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.

• Subjects with mild to moderate Crohn's disease.

• All subjects must have a stool analysis negative for Clostridium difficile toxin, Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days prior to visit 1.

• All subjects must have had laboratory assessments within 7 days prior to visit 1.

• All subjects must weigh >= 15 kg at time of enrollment

Exclusion Criteria:

• Subjects who have had any previous intestinal resection proximal to and including the ascending colon

• Subjects with evidence of severe active Crohn's disease and/or, stricturing and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications

• Subjects who do not have a negative stool analysis, within the 30 days prior to visit 1

• Subjects who have been screened/or enrolled in this study previously within the last 30 days

• Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Aurora	Colorado	United States
2	Research Site	Atlanta	Georgia	United States
3	Research Site	Chicago	Illinois	United States
4	Research Site	Oak Lawn	Illinois	United States
5	Research Site	Boston	Massachusetts	United States
6	Research Site	Saint Paul	Minnesota	United States
7	Research Site	Mays Landing	New Jersey	United States
8	Research Site	Morristown	New Jersey	United States
9	Research Site	Buffalo	New York	United States
10	Research Site	Greenville	North Carolina	United States
11	Research Site	Nashville	Tennessee	United States
12	Research Site	Halifax	Nova Scotia	Canada
13	Research Site	London	Ontario	Canada
14	Research Site	Toronto	Ontario	Canada
15	Research Site	München		Germany
16	Research Site	Firenze		Italy
17	Research Site	Messina		Italy
18	Research Site	Napoli		Italy
19	Research Site	Roma		Italy
20	Research Site	Kraków		Poland
21	Research Site	Rzeszów		Poland
22	Research Site	Warszawa		Poland
23	Research Site	Wrocław		Poland
24	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 and Emory University School of Medicine, 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: NCT01444092
• Other Study ID Numbers: D9422C00001
• First Posted: Sep 30, 2011
• Last Update Posted: Jan 6, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Crohn Disease; Budesonide

Study Results

Participant Flow

Recruitment Details	123 patients were screened/enrolled, but only 108 received treatment. The other 15 did not meet the inclusion/exclusion criteria. They only appear in the disposition tables in the CSR (Tables 8 and 10) and did not "start" in the study.
Pre-assignment Detail	123 patients were screened/enrolled, but only 108 received treatment. The other 15 did not meet the inclusion/exclusion criteria. They only appear in the disposition tables in the CSR (Tables 8 and 10) and did not "start" in the study.

Arm/Group Title	Entocort
Arm/Group Description	Entocort™ EC 9/6/3 mg
Period Title: Overall Study
STARTED	108
INFORMED CONSENT OBTAINED	108
COMPLETED	91
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Entocort
Arm/Group Description	Entocort™ EC 9/6/3 mg
Overall Participants	108
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	13.7 (2.41)
Age, Customized (Number) [Number]
=<8 Yrs	5 4.6%
>8 Yrs	103 95.4%
Sex: Female, Male (Count of Participants)
Female	51 47.2%
Male	57 52.8%
Race/Ethnicity, Customized (Number) [Number]
Asian	1 0.9%
Black Or African American	4 3.7%
Other	3 2.8%
White	100 92.6%

Outcome Measures

1. Primary Outcome

Title	Adverse Event
Description	Number of patients with at least one adverse event
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Entocort
Arm/Group Description	Entocort™ EC 9/6/3 mg
Measure Participants	108
Number [Patients]	79

2. Secondary Outcome

Title	PCDAI
Description	Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Entocort
Arm/Group Description	Entocort™ EC 9/6/3 mg
Measure Participants	105
Baseline (Day1)	19.10 (10.1)
Change after 8 weeks	-10.0 (10.1)

3. Secondary Outcome

Title	IMPACT 3
Description	IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set

Arm/Group Title	Entocort
Arm/Group Description	Entocort™ EC 9/6/3 mg
Measure Participants	107
Baseline (Day 1)	132.1 (18.8)
Change after 8 weeks	7.8 (13.3)

Adverse Events

Arm/Group Title	Entocort
Arm/Group Description	Entocort™ EC 9/6/3 mg
All Cause Mortality
	Entocort
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Entocort
	Affected / at Risk (%)	# Events
Total	8/108 (7.4%)
Gastrointestinal disorders
Crohn's disease	4/108 (3.7%)	4
Diarrhoea haemorrhagic	1/108 (0.9%)	1
Small intestinal obstruction	1/108 (0.9%)	1
Metabolism and nutrition disorders
Hypokalaemia	1/108 (0.9%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/108 (0.9%)	1
Skin and subcutaneous tissue disorders
Erythema nodosum	1/108 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Entocort
	Affected / at Risk (%)	# Events
Total	78/108 (72.2%)
Blood and lymphatic system disorders
Anaemia	5/108 (4.6%)	5
Increased tendency to bruise	1/108 (0.9%)	1
Lymphadenopathy	1/108 (0.9%)	1
Cardiac disorders
Tachycardia	2/108 (1.9%)	2
Endocrine disorders
Cushingoid	13/108 (12%)	13
Eye disorders
Iritis	1/108 (0.9%)	1
Scleritis	1/108 (0.9%)	1
Gastrointestinal disorders
Abdominal distension	1/108 (0.9%)	1
Abdominal mass	1/108 (0.9%)	1
Abdominal pain	16/108 (14.8%)	16
Abdominal pain lower	1/108 (0.9%)	1
Abdominal tenderness	1/108 (0.9%)	1
Anal fissure	2/108 (1.9%)	2
Anal haemorrhage	1/108 (0.9%)	1
Anal skin tags	1/108 (0.9%)	1
Breath odour	1/108 (0.9%)	1
Cheilosis	1/108 (0.9%)	1
Constipation	2/108 (1.9%)	2
Crohn's disease	7/108 (6.5%)	7
Diarrhoea	2/108 (1.9%)	2
Dyspepsia	3/108 (2.8%)	3
Enterocolitis	2/108 (1.9%)	2
Haematochezia	3/108 (2.8%)	3
Nausea	6/108 (5.6%)	6
Proctalgia	1/108 (0.9%)	1
Rectal haemorrhage	2/108 (1.9%)	2
Vomiting	5/108 (4.6%)	5
General disorders
Chest pain	1/108 (0.9%)	1
Influenza like illness	1/108 (0.9%)	1
Malaise	1/108 (0.9%)	1
Pyrexia	3/108 (2.8%)	3
Tenderness	1/108 (0.9%)	1
Infections and infestations
Acarodermatitis	1/108 (0.9%)	1
Conjunctivitis	1/108 (0.9%)	1
Enteritis infectious	1/108 (0.9%)	1
Gastroenteritis	2/108 (1.9%)	2
Nasopharyngitis	4/108 (3.7%)	4
Otitis externa	1/108 (0.9%)	1
Pharyngitis	4/108 (3.7%)	4
Rectal abscess	1/108 (0.9%)	1
Rhinitis	1/108 (0.9%)	1
Tooth abscess	1/108 (0.9%)	1
Upper respiratory tract infection	3/108 (2.8%)	3
Urinary tract infection	1/108 (0.9%)	1
Viral infection	1/108 (0.9%)	1
Viral pharyngitis	1/108 (0.9%)	1
Injury, poisoning and procedural complications
Concussion	1/108 (0.9%)	1
Contusion	1/108 (0.9%)	1
Incision site complication	1/108 (0.9%)	1
Procedural pain	1/108 (0.9%)	1
Investigations
Activated partial thromboplastin time prolonged	1/108 (0.9%)	1
Blood albumin decreased	1/108 (0.9%)	1
Blood cortisol decreased	1/108 (0.9%)	1
Blood cortisol increased	1/108 (0.9%)	1
C-reactive protein increased	2/108 (1.9%)	2
Haemoglobin decreased	1/108 (0.9%)	1
Mean cell volume decreased	1/108 (0.9%)	1
Occult blood positive	1/108 (0.9%)	1
Protein urine present	1/108 (0.9%)	1
Red blood cell sedimentation rate increased	3/108 (2.8%)	3
Urine output decreased	1/108 (0.9%)	1
Metabolism and nutrition disorders
Decreased appetite	6/108 (5.6%)	6
Dehydration	1/108 (0.9%)	1
Hyperamylasaemia	1/108 (0.9%)	1
Hyperphagia	1/108 (0.9%)	1
Increased appetite	17/108 (15.7%)	17
Musculoskeletal and connective tissue disorders
Arthralgia	1/108 (0.9%)	1
Back pain	2/108 (1.9%)	2
Fistula	1/108 (0.9%)	1
Musculoskeletal discomfort	1/108 (0.9%)	1
Musculoskeletal pain	2/108 (1.9%)	2
Myalgia	1/108 (0.9%)	1
Osteoporosis	1/108 (0.9%)	1
Pain in extremity	1/108 (0.9%)	1
Nervous system disorders
Disturbance in attention	3/108 (2.8%)	3
Dizziness	1/108 (0.9%)	1
Headache	9/108 (8.3%)	9
Lethargy	1/108 (0.9%)	1
Memory impairment	4/108 (3.7%)	4
Migraine	1/108 (0.9%)	1
Psychomotor hyperactivity	1/108 (0.9%)	1
Syncope	1/108 (0.9%)	1
Psychiatric disorders
Affect lability	1/108 (0.9%)	1
Agitation	2/108 (1.9%)	2
Anxiety	1/108 (0.9%)	1
Depression	2/108 (1.9%)	2
Insomnia	6/108 (5.6%)	6
Irritability	14/108 (13%)	14
Mood swings	3/108 (2.8%)	3
Sleep disorder	1/108 (0.9%)	1
Renal and urinary disorders
Haematuria	1/108 (0.9%)	1
Reproductive system and breast disorders
Dysmenorrhoea	1/108 (0.9%)	1
Menstrual disorder	2/108 (1.9%)	2
Metrorrhagia	1/108 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Cough	3/108 (2.8%)	3
Respiratory tract congestion	1/108 (0.9%)	1
Skin and subcutaneous tissue disorders
Acne	15/108 (13.9%)	15
Alopecia	2/108 (1.9%)	2
Dry skin	1/108 (0.9%)	1
Erythema nodosum	2/108 (1.9%)	2
Hair growth abnormal	1/108 (0.9%)	1
Hirsutism	5/108 (4.6%)	5
Lipohypertrophy	1/108 (0.9%)	1
Pruritus	1/108 (0.9%)	1
Rash	2/108 (1.9%)	2
Skin striae	2/108 (1.9%)	2
Vascular disorders
Pallor	1/108 (0.9%)	1

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.