Clinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX® 9 mg extended-release tablets in patients with active left-sided ulcerative colitis

J Crohns Colitis. 2010 Jun;4(2):153-60. doi: 10.1016/j.crohns.2009.09.007. Epub 2009 Oct 24.


Background: Ulcerative colitis (UC) is a chronic inflammatory disease with relapses. Many patients need systemic corticosteroids to induce clinical remission.

Aim: Efficacy and safety of Budesonide-MMX® 9 mg tablets, a new oral, extended-release formulation, were evaluated in patients suffering from active, left-sided UC with colitis activity index (CAI) <14.

Methods: 36 patients were treated once daily for 4 weeks with Budesonide-MMX® 9 mg tablets or placebo. In an additional 4-week period, all patients received Budesonide-MMX®. CAI, endoscopic index and histology were assessed after 4 and 8 weeks. Primary end-point was remission, and/or CAI reduction by 50% after 4 weeks. Morning cortisol was assayed after 4 and 8 weeks, and a short ACTH-test was performed at week 8.

Results: 32 patients were analysed. After 4 weeks, 47.1% of the patients in the Budesonide-MMX® 9 mg tablets group achieved the primary end-point vs. 33.3% of patients on placebo. In addition, 47.1% of budesonide patients and another 33.3% of placebo recipients improved without remission by 4 weeks. The CAI reduction was significant with Budesonide (p<0.0001) tablets and not with placebo (p=0.1). Neither morning cortisol nor pituitary-adrenal axis was more frequently suppressed with Budesonide tablets than with placebo.

Conclusions: Budesonide-MMX® 9 mg tablets induced a fast and significant clinical improvement of active left-sided UC without suppression of adrenocortical functions and without important toxicity EudraCT number 2004-000896-33.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Biomarkers / metabolism
  • Biopsy
  • Budesonide / administration & dosage
  • Budesonide / adverse effects
  • Budesonide / therapeutic use*
  • C-Reactive Protein / metabolism
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / metabolism
  • Colitis, Ulcerative / pathology
  • Colonoscopy
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Intestinal Mucosa / pathology
  • Male
  • Middle Aged
  • Pilot Projects
  • Remission Induction
  • Severity of Illness Index
  • Tablets, Enteric-Coated
  • Treatment Outcome


  • Anti-Inflammatory Agents
  • Biomarkers
  • Tablets, Enteric-Coated
  • Budesonide
  • C-Reactive Protein