Crohn's Disease
Conditions
Keywords
Crohn's Disease
Brief summary
A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
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
Interventions
DRUGEntocort
Entocort capsules, taken orally, 6 mg daily.
Sponsors
Padagis LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 16 weeks | Any kind of adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCDAI | 12 weeks | Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity) |
| IMPACT 3 | 12 weeks | IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE |
Countries
Canada, Germany, Italy, Poland, United States
Participant flow
Recruitment details
In this study, 55 patients were enrolled but only 50 fulfilled the enrolment criteria.
Pre-assignment details
55 patients were enrolled but only 50 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Entocort Entocort 6 mg/day | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Did not receive drug for the taper phase | 1 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Entocort |
|---|---|
| Age, Continuous | 13.8 years |
| Age, Customized <=8 years | 2 participants |
| Age, Customized >8 years | 48 participants |
| Race/Ethnicity, Customized Black or african american | 2 participants |
| Race/Ethnicity, Customized Other | 3 participants |
| Race/Ethnicity, Customized White | 45 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 50 |
| serious Total, serious adverse events | 4 / 50 |
Outcome results
Primary
Adverse Event
Any kind of adverse event
Time frame: 16 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entocort | Adverse Event | 37 Subjects |
Secondary
IMPACT 3
IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Time frame: 12 weeks
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entocort | IMPACT 3 | Baseline | 146.6 Score units | Standard Deviation 12.4 |
| Entocort | IMPACT 3 | Change after 12 weeks | 1.2 Score units | Standard Deviation 8.6 |
| Entocort | IMPACT 3 | 12 weeks | 147.0 Score units | Standard Deviation 15.5 |
Secondary
PCDAI
Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entocort | PCDAI | Baseline | 4.9 Scores on a scale | Standard Deviation 3.6 |
| Entocort | PCDAI | Change after 12 weeks | 2.0 Scores on a scale | Standard Deviation 7 |
| Entocort | PCDAI | 12 weeks | 6.9 Scores on a scale | Standard Deviation 8.1 |