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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747110
• Other study ID #: BUC-57/UCA
• Secondary ID: 2006-005377-22
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2008
• Last updated: June 25, 2012
• Start date: October 2007
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: August 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• budesonide
3x 3mg budesonide capsules once daily
• mesalazine
3x 1000mg mesalazine onc daily

Locations

Country	Name	City	State
Germany	Klinikum St. Marien	Amberg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 achiev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF)		week 8 (LOCF)	No
Secondary	Time to first resolution of clinical symptoms		within 8 weeks	No
Secondary	CAI in the course of the study		week 0, 2, 4, 6, 8	No
Secondary	Disease Activity Index (DAI)in the course of the study		week 0 and 8 (LOCF)	No
Secondary	Endoscopical Index (EI)in the course of the study		week 0 and 8 (LOCF)	No