Trial Outcomes & Findings for Safety Study of Entocort for Children With Crohn's Disease (NCT NCT01444092)
NCT ID: NCT01444092
Last Updated: 2022-01-06
Results Overview
Number of patients with at least one adverse event
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-01-06
Participant Flow
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.
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.
Participant milestones
| Measure |
Entocort
Entocort™ EC 9/6/3 mg
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
INFORMED CONSENT OBTAINED
|
108
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Entocort
Entocort™ EC 9/6/3 mg
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other Eligibility criteria
|
7
|
Baseline Characteristics
Safety Study of Entocort for Children With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Entocort
n=108 Participants
Entocort™ EC 9/6/3 mg
|
|---|---|
|
Age, Continuous
|
13.7 Years
STANDARD_DEVIATION 2.41 • n=5 Participants
|
|
Age, Customized
=<8 Yrs
|
5 Participants
n=5 Participants
|
|
Age, Customized
>8 Yrs
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety analysis set
Number of patients with at least one adverse event
Outcome measures
| Measure |
Entocort
n=108 Participants
Entocort™ EC 9/6/3 mg
|
|---|---|
|
Adverse Event
|
79 Patients
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Full analysis set
Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
Outcome measures
| Measure |
Entocort
n=105 Participants
Entocort™ EC 9/6/3 mg
|
|---|---|
|
PCDAI
Baseline (Day1)
|
19.10 Units on a scale
Standard Deviation 10.1
|
|
PCDAI
Change after 8 weeks
|
-10.0 Units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Safety analysis set
IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
Outcome measures
| Measure |
Entocort
n=107 Participants
Entocort™ EC 9/6/3 mg
|
|---|---|
|
IMPACT 3
Baseline (Day 1)
|
132.1 Units on a scale
Standard Deviation 18.8
|
|
IMPACT 3
Change after 8 weeks
|
7.8 Units on a scale
Standard Deviation 13.3
|
Adverse Events
Entocort
Serious events: 8 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entocort
n=108 participants at risk
Entocort™ EC 9/6/3 mg
|
|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
3.7%
4/108 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.93%
1/108 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.93%
1/108 • Number of events 1
|
Other adverse events
| Measure |
Entocort
n=108 participants at risk
Entocort™ EC 9/6/3 mg
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.6%
5/108 • Number of events 5
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.93%
1/108 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.93%
1/108 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
1.9%
2/108 • Number of events 2
|
|
Endocrine disorders
Cushingoid
|
12.0%
13/108 • Number of events 13
|
|
Eye disorders
Iritis
|
0.93%
1/108 • Number of events 1
|
|
Eye disorders
Scleritis
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal mass
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
14.8%
16/108 • Number of events 16
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Anal fissure
|
1.9%
2/108 • Number of events 2
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Anal skin tags
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Breath odour
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Cheilosis
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/108 • Number of events 2
|
|
Gastrointestinal disorders
Crohn's disease
|
6.5%
7/108 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/108 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
3/108 • Number of events 3
|
|
Gastrointestinal disorders
Enterocolitis
|
1.9%
2/108 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
2.8%
3/108 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
5.6%
6/108 • Number of events 6
|
|
Gastrointestinal disorders
Proctalgia
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.9%
2/108 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
5/108 • Number of events 5
|
|
General disorders
Chest pain
|
0.93%
1/108 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.93%
1/108 • Number of events 1
|
|
General disorders
Malaise
|
0.93%
1/108 • Number of events 1
|
|
General disorders
Pyrexia
|
2.8%
3/108 • Number of events 3
|
|
General disorders
Tenderness
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Acarodermatitis
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Enteritis infectious
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.9%
2/108 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
4/108 • Number of events 4
|
|
Infections and infestations
Otitis externa
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
3.7%
4/108 • Number of events 4
|
|
Infections and infestations
Rectal abscess
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
3/108 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Viral pharyngitis
|
0.93%
1/108 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.93%
1/108 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.93%
1/108 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.93%
1/108 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Blood albumin decreased
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Blood cortisol decreased
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Blood cortisol increased
|
0.93%
1/108 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
1.9%
2/108 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Mean cell volume decreased
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Occult blood positive
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Protein urine present
|
0.93%
1/108 • Number of events 1
|
|
Investigations
Red blood cell sedimentation rate increased
|
2.8%
3/108 • Number of events 3
|
|
Investigations
Urine output decreased
|
0.93%
1/108 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
6/108 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/108 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.93%
1/108 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.93%
1/108 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
15.7%
17/108 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/108 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
2/108 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.93%
1/108 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
2.8%
3/108 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.3%
9/108 • Number of events 9
|
|
Nervous system disorders
Lethargy
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.7%
4/108 • Number of events 4
|
|
Nervous system disorders
Migraine
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.93%
1/108 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Affect lability
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
1.9%
2/108 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.9%
2/108 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
5.6%
6/108 • Number of events 6
|
|
Psychiatric disorders
Irritability
|
13.0%
14/108 • Number of events 14
|
|
Psychiatric disorders
Mood swings
|
2.8%
3/108 • Number of events 3
|
|
Psychiatric disorders
Sleep disorder
|
0.93%
1/108 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.93%
1/108 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.93%
1/108 • Number of events 1
|
|
Reproductive system and breast disorders
Menstrual disorder
|
1.9%
2/108 • Number of events 2
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.93%
1/108 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
3/108 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
13.9%
15/108 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
2/108 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
1.9%
2/108 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
4.6%
5/108 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.93%
1/108 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/108 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
1.9%
2/108 • Number of events 2
|
|
Vascular disorders
Pallor
|
0.93%
1/108 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place