Budesonide 9 mg Capsules in Active UC

Phase 2

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Budesonide

• Registration Number: NCT02550418
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Study Start: 2015-10
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Signed informed consent,
• Men or women aged 18 to 75 years,
• Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
• Established disease,

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Exclusion Criteria

• Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
• Toxic megacolon or fulminant colitis,
• Colon resection,
• Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
• Malabsorption syndromes,
• Celiac disease,
• Bleeding hemorrhoids,
• Active peptic ulcer disease
• Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
• Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
• Any severe infectious disease (e.g., tuberculosis, AIDS),
• Severe co-morbidity substantially reducing life expectancy,
• History of colorectal cancer,
• History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Budesonide	Budesonide	-

Primary Outcome Measures

Name	Time	Method
Rate of clinical remission at final/withdrawal visit	8 weeks treatment	Clinical remission includes normalisation of stool frequency and absence of blood in stools

Secondary Outcome Measures

Name	Time	Method
Rate of endoscopic remission/improvement at final/withdrawal visit	8 weeks treatment
Number of stools / bloody stools per week	8 weeks treatment

Trial Locations

Locations (1)

University of Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany