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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00747110
• Date of registration: 03/09/2008
• Prospective Registration: No
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
• Scientific 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
• Date of first enrolment: October 2007
• Target sample size: 343
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00747110
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Ralph Mueller, Dr
• Affiliation: Dr. Falk Pharma GmbH

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: mesalazine

Drug: budesonide

Primary Outcome(s)

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(s)

Disease Activity Index (DAI)in the course of the study [Time Frame: week 0 and 8 (LOCF)]

CAI in the course of the study [Time Frame: week 0, 2, 4, 6, 8]

Endoscopical Index (EI)in the course of the study [Time Frame: week 0 and 8 (LOCF)]

Time to first resolution of clinical symptoms [Time Frame: within 8 weeks]

Secondary ID(s)

BUC-57/UCA

2006-005377-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors