EUCTR2008-006957-42-LT
Active, not recruiting
Not Applicable
Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease
ConditionsInduction of remission in active Crohn´s diseaseMedDRA version: 14.0Level: LLTClassification code 10058815Term: Crohn's disease acute episodeSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Induction of remission in active Crohn´s disease
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent,
- •2\. Age 18 to 75 years,
- •3\. Symptoms of Crohn’s disease since at least 3 months; diagnosis confirmed
- •by endoscopic and histological, or endoscopic and radiological criteria
- •\[endoscopy not older than 12 months or if older, then clinical signs (e.g.,pain localisation, pain intensity, blood in stool) and behaviour (according to
- •Montreal classification) should be unchanged compared to former episodes],
- •4\. Localisation of CD either in terminal ileum, coecum, ascending colon, or
- •ileocolitis,
- •5\. Active phase of disease (200 \< CDAI \< 400\),
- •6\. Negative pregnancy test in females of childbearing potential,
Exclusion Criteria
- •1\. Known Crohn’s lesions in the upper GI\-tract (up to and including the
- •jejunum) or rectum with present symptoms,
- •2\. Septic complications,
- •3\. Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
- •4\. Abscess, perforation, or active fistulas,
- •5\. Ileostomy or colostomy,
- •6\. Resection of more than 50 cm of the ileum,
- •7\. Bowel surgery within the last 3 months,
- •8\. Immediate surgery required (e.g., major stenosis, serious bleeding,
- •peritonitis, ileus),
Outcomes
Primary Outcomes
Not specified
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Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseEUCTR2008-006957-42-LVDr. Falk Pharma GmbH400
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Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseInduction of remission in active Crohn´s diseaseMedDRA version: 12.0Level: LLTClassification code 10058815Term: Crohn's disease acute episodeMedDRA version: 12.0Level: PTClassification code 10011401Term: Crohn's diseaseEUCTR2008-006957-42-HUDr. Falk Pharma GmbH400
Active, not recruiting
Not Applicable
Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseInduction of remission in active Crohn´s diseaseMedDRA version: 12.0Level: LLTClassification code 10058815Term: Crohn's disease acute episodeMedDRA version: 12.0Level: PTClassification code 10011401Term: Crohn's diseaseEUCTR2008-006957-42-SKDr. Falk Pharma GmbH400
Active, not recruiting
Not Applicable
Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseInduction of remission in active Crohn´s diseaseMedDRA version: 12.0Level: LLTClassification code 10058815Term: Crohn's disease acute episodeMedDRA version: 12.0Level: PTClassification code 10011401Term: Crohn's diseaseEUCTR2008-006957-42-CZDr. Falk Pharma GmbH400
Active, not recruiting
Not Applicable
Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseEUCTR2008-006957-42-BGDr. Falk Pharma GmbH400