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

NCT ID: NCT00747110

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-08-31

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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

9mg budesonide OD

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

3x 3mg budesonide capsules once daily

B

3g mesalazine OD

Group Type: ACTIVE_COMPARATOR

mesalazine

Intervention Type: DRUG

3x 1000mg mesalazine onc daily

Interventions

budesonide

3x 3mg budesonide capsules once daily

Intervention Type: DRUG

mesalazine

3x 1000mg mesalazine onc daily

Intervention Type: DRUG

Other Intervention Names

Budenofalk 3mg capsules; Salofalk 1000mg granules

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Mueller, Dr

Role: STUDY_DIRECTOR

Dr. Falk Pharma GmbH

Locations

Klinikum St. Marien

Amberg, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 21453882 (View on PubMed)

Other Identifiers

2006-005377-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BUC-57/UCA

Identifier Type: -

Identifier Source: org_study_id