Trial Outcomes & Findings for Safety and Maintenance Study of Entocort for Children With Crohn's Disease (NCT NCT01453946)

NCT ID: NCT01453946

Last Updated: 2022-01-06

Results Overview

Any kind of adverse event

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 55 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2022-01-06

Participant Flow

In this study, 55 patients were enrolled but only 50 fulfilled the enrolment criteria.

55 patients were enrolled but only 50 received treatment.

Participant milestones

Measure	Entocort Entocort 6 mg/day
Overall Study STARTED	50
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Entocort Entocort 6 mg/day
Overall Study Did not receive drug for the taper phase	1
Overall Study Protocol Violation	2
Overall Study Lack of Efficacy	3
Overall Study Adverse Event	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Entocort n=50 Participants Entocort 6 mg/day
Age, Continuous	13.8 years n=5 Participants
Age, Customized <=8 years	2 participants n=5 Participants
Age, Customized >8 years	48 participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized White	45 participants n=5 Participants
Race/Ethnicity, Customized Black or african american	2 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Safety analysis set

Any kind of adverse event

Outcome measures

Measure	Entocort n=50 Participants Entocort 6 mg/day
Adverse Event	37 Subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: Full Analysis Set

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

Outcome measures

Measure	Entocort n=49 Participants Entocort 6 mg/day
PCDAI Baseline	4.9 Scores on a scale Standard Deviation 3.6
PCDAI Change after 12 weeks	2.0 Scores on a scale Standard Deviation 7.0
PCDAI 12 weeks	6.9 Scores on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: 12 weeks

Population: Safety analysis set

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

Outcome measures

Measure	Entocort n=50 Participants Entocort 6 mg/day
IMPACT 3 Change after 12 weeks	1.2 Score units Standard Deviation 8.6
IMPACT 3 12 weeks	147.0 Score units Standard Deviation 15.5
IMPACT 3 Baseline	146.6 Score units Standard Deviation 12.4

Adverse Events

Entocort

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Entocort n=50 participants at risk Entocort 6 mg/day
Gastrointestinal disorders Crohn's disease	6.0% 3/50 • Number of events 3 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Gastrointestinal haemhorrage	2.0% 1/50 • Number of events 1 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Ileal stenosis	2.0% 1/50 • Number of events 1 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug

Other adverse events

Measure	Entocort n=50 participants at risk Entocort 6 mg/day
Gastrointestinal disorders Abdominal pain	16.0% 8/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Crohn's disease	8.0% 4/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Dyspepsia	6.0% 3/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Diarrhoea	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Haematochizia	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Gastrointestinal disorders Vomiting	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Infections and infestations Nasopharyngitis	6.0% 3/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Infections and infestations Upper respiratory tract infection	6.0% 3/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Infections and infestations Gastroenteritis	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Infections and infestations Gastroenteritis viral	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Skin and subcutaneous tissue disorders Acne	12.0% 6/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Skin and subcutaneous tissue disorders Hirsutism	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 3/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Metabolism and nutrition disorders Increased appetite	8.0% 4/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Metabolism and nutrition disorders Decreased appetite	6.0% 3/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
General disorders Irritability	8.0% 4/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Psychiatric disorders Mood swings	8.0% 4/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Nervous system disorders Headache	4.0% 2/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
Endocrine disorders Cushingoid	8.0% 4/50 • 16 weeks 12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug

Additional Information

Beatriz North

Perrigo

Phone: 718-960-0163

Email: beatriz.north@perrigo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place