Budesonide 9 mg Capsules in Active UC

NCT02550418 | Completed Phase 2

• 1 other identifier: BUX-3/UCA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of endoscopic remission/improvement at final/withdrawal visit

  8 weeks treatment

• Number of stools / bloody stools per week

  8 weeks treatment

Study Arms (1)

Budesonide

EXPERIMENTAL

Drug: Budesonide

Interventions

Budesonide DRUG

Budesonide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Falk Pharma GmbH: lead

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (1)

• Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7.

  PMID: 33028169 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Klaus Fellermann, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 15, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

DE (1)