Budesonide 9 mg Capsules in Active UC

Overview

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

Full Title of Study: “Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

Interventions

  • Drug: Budesonide

Arms, Groups and Cohorts

  • Experimental: Budesonide

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Rate of endoscopic remission/improvement at final/withdrawal visit
    • Time Frame: 8 weeks treatment
  • Number of stools / bloody stools per week
    • Time Frame: 8 weeks treatment

Participating in This Clinical Trial

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, 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Falk Pharma GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Klaus Fellermann, MD, Principal Investigator, University Hospital Schleswig-Holstein

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