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Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747110
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date June 26, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) [ Time Frame: week 8 (LOCF) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00747110 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • Time to first resolution of clinical symptoms [ Time Frame: within 8 weeks ]
  • CAI in the course of the study [ Time Frame: week 0, 2, 4, 6, 8 ]
  • Disease Activity Index (DAI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ]
  • Endoscopical Index (EI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
Official Title  ICMJE Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis
Brief Summary The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: budesonide
    3x 3mg budesonide capsules once daily
    Other Name: Budenofalk 3mg capsules
  • Drug: mesalazine
    3x 1000mg mesalazine onc daily
    Other Name: Salofalk 1000mg granules
Study Arms  ICMJE
  • Experimental: A
    9mg budesonide OD
    Intervention: Drug: budesonide
  • Active Comparator: B
    3g mesalazine OD
    Intervention: Drug: mesalazine
Publications * Gross V, Bunganic I, Belousova EA, Mikhailova TL, Kupcinskas L, Kiudelis G, Tulassay Z, Gabalec L, Dorofeyev AE, Derova J, Dilger K, Greinwald R, Mueller R; International BUC-57 Study Group. 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2011 Apr;5(2):129-38. doi: 10.1016/j.crohns.2010.11.006. Epub 2010 Dec 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2008)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent,
  2. Men or women aged 18 to 75 years,
  3. Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
  4. Established disease (presence of blood or mucus in the stools) or new diagnosis (bloody stools occurring at least during 14 days prior to baseline visit),
  5. Clinical Activity Index (CAI) >= 6 and Endoscopical Index (EI) >= 4,
  6. Women of child-bearing potential, if heterosexually active, have to apply a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptive method, some intrauterine devices (IUDs), sexual abstinence, or vasectomised partner. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion Criteria:

  1. Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
  2. Toxic megacolon,
  3. Baseline stool positive for germs causing bowel disease,
  4. Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract,
  5. Active peptic ulcer disease,
  6. Haemorrhagic diathesis,
  7. Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured,
  8. Severe co-morbidity substantially reducing life expectancy,
  9. Active colorectal cancer or a history of colorectal cancer,
  10. Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible,
  11. Immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 4 weeks prior to baseline,
  12. Current relapse occurred under maintenance treatment with > 2.4 g mesalazine per day,
  13. Abnormal renal function (Serum Cystatin C > upper limit of normal [ULN]),
  14. Abnormal hepatic function (ALT, AST or AP >= 2 x ULN) or liver cirrhosis,
  15. Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drugs,
  16. Doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
  17. Existing or intended pregnancy or breast-feeding,
  18. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00747110
Other Study ID Numbers  ICMJE BUC-57/UCA
2006-005377-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Falk Pharma GmbH
Study Sponsor  ICMJE Dr. Falk Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ralph Mueller, Dr Dr. Falk Pharma GmbH
PRS Account Dr. Falk Pharma GmbH
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP