Budesonide 9 mg Capsules in Active UC

Colitis, Ulcerative Clinical Trial

— TOPICAL-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550418
• Other study ID #: BUX-3/UCA
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2015
• Last updated: July 25, 2017
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Budesonide

Locations

Country	Name	City	State
Germany	University of Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission at final/withdrawal visit	Clinical remission includes normalisation of stool frequency and absence of blood in stools	8 weeks treatment
Secondary	Rate of endoscopic remission/improvement at final/withdrawal visit		8 weeks treatment
Secondary	Number of stools / bloody stools per week		8 weeks treatment