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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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: budesonide
Drug: mesalazine
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)
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)]
Disease Activity Index (DAI)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)
2006-005377-22
BUC-57/UCA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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