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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

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: budesonide Drug: mesalazine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: A
9mg budesonide OD
Drug: budesonide
3x 3mg budesonide capsules once daily
Other Name: Budenofalk 3mg capsules

Active Comparator: B
3g mesalazine OD
Drug: mesalazine
3x 1000mg mesalazine onc daily
Other Name: Salofalk 1000mg granules

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Time to first resolution of clinical symptoms [ Time Frame: within 8 weeks ]
  2. CAI in the course of the study [ Time Frame: week 0, 2, 4, 6, 8 ]
  3. Disease Activity Index (DAI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ]
  4. Endoscopical Index (EI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747110

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Klinikum St. Marien
Amberg, Germany, 92224
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Study Director: Ralph Mueller, Dr Dr. Falk Pharma GmbH

Publications of Results:
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00747110     History of Changes
Other Study ID Numbers: BUC-57/UCA
2006-005377-22 ( EudraCT Number )
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
Keywords provided by Dr. Falk Pharma GmbH:
ulcerative colitis
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents