Crohn's Disease
Conditions
Brief summary
A Safety Study using 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 for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
Interventions
DRUGEntocort
Entocort capsules, oral
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 12 weeks | Number of patients with at least one adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCDAI | Baseline to 8 weeks | Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst). |
| IMPACT 3 | Baseline to 8 weeks | IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best). |
Countries
Canada, Germany, Italy, Poland, United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| Entocort Entocort™ EC 9/6/3 mg | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Other Eligibility criteria | 7 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Entocort |
|---|---|
| Age, Continuous | 13.7 Years STANDARD_DEVIATION 2.41 |
| Age, Customized =<8 Yrs | 5 Participants |
| Age, Customized >8 Yrs | 103 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black Or African American | 4 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 100 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 108 |
| serious Total, serious adverse events | 8 / 108 |
Outcome results
Primary
Adverse Event
Number of patients with at least one adverse event
Time frame: 12 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entocort | Adverse Event | 79 Patients |
Secondary
IMPACT 3
IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
Time frame: Baseline to 8 weeks
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entocort | IMPACT 3 | Baseline (Day 1) | 132.1 Units on a scale | Standard Deviation 18.8 |
| Entocort | IMPACT 3 | Change after 8 weeks | 7.8 Units on a scale | Standard Deviation 13.3 |
Secondary
PCDAI
Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
Time frame: Baseline to 8 weeks
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entocort | PCDAI | Baseline (Day1) | 19.10 Units on a scale | Standard Deviation 10.1 |
| Entocort | PCDAI | Change after 8 weeks | -10.0 Units on a scale | Standard Deviation 10.1 |