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A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entocort | Other | Study Medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entocort | Drug | Entocort capsules, taken orally, 6 mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Any kind of adverse event | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PCDAI | Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity) | 12 weeks |
| IMPACT 3 | IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Cohen, MD | Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA | Principal Investigator |
| Stefan Eklund, MD | AstraZeneca Pharmaceuticals, Mölndal, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Atlanta | Georgia | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28420280 | Derived | Cohen SA, Aloi M, Arumugam R, Baker R, Bax K, Kierkus J, Koletzko S, Lionetti P, Persson T, Eklund S. Enteric-coated budesonide for the induction and maintenance of remission of Crohn's disease in children. Curr Med Res Opin. 2017 Jul;33(7):1261-1268. doi: 10.1080/03007995.2017.1313213. Epub 2017 Apr 19. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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55 patients were enrolled but only 50 received treatment.
In this study, 55 patients were enrolled but only 50 fulfilled the enrolment criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entocort | Entocort 6 mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 12 weeks |
| Oak Lawn |
| Illinois |
| United States |
| Research Site | Newton | Massachusetts | United States |
| Research Site | Saint Paul | Minnesota | United States |
| Research Site | Mays Landing | New Jersey | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | München | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Florence | Italy |
| Research Site | Messina | Italy |
| Research Site | Roma | Italy |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Rzeszów | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entocort | Entocort 6 mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | PCDAI | Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity) | Full Analysis Set | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | IMPACT 3 | IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE | Safety analysis set | Posted | Mean | Standard Deviation | Score units | 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Adverse Event | Any kind of adverse event | Safety analysis set | Posted | Number | Subjects | 16 weeks |
|
|
|
16 weeks
12 weeks on 6 mg/day followed by 2 weeks on 3 mg/day and 2 weeks without active drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entocort | Entocort 6 mg/day | 4 | 50 | 36 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders |
| |||
| Gastrointestinal haemhorrage | Gastrointestinal disorders |
| |||
| Ileal stenosis | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| |||
| Crohn's disease | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Haematochizia | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Gastroenteritis viral | Infections and infestations |
| |||
| Acne | Skin and subcutaneous tissue disorders |
| |||
| Hirsutism | Skin and subcutaneous tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Increased appetite | Metabolism and nutrition disorders |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Irritability | General disorders |
| |||
| Mood swings | Psychiatric disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Cushingoid | Endocrine disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beatriz North | Perrigo | 718-960-0163 | beatriz.north@perrigo.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Other |
|
| Title | Measurements |
|---|---|
|
| Baseline |
| |||||
| Change after 12 weeks |
| |||||
| 12 weeks |
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