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Completed

NCT Number: NCT02550418

Budesonide 9 mg Capsules in Active UC

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

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

Primary outcomes

  1. 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 outcomes

  1. Rate of endoscopic remission/improvement at final/withdrawal visit

    Time frame: 8 weeks treatment

  2. Number of stools / bloody stools per week

    Time frame: 8 weeks treatment

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Acronym: TOPICAL-1

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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