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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2004-001218-15-LV
Date of registration: 30/05/2005
Prospective Registration: Yes
Primary sponsor: Dr. Falk Pharma GmbH
Public title: Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC
Scientific title: Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC
Date of first enrolment: 30/05/2005
Target sample size: 510
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001218-15
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double-dummy If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: different dosage and dosage scheme  
Phase: 
Countries of recruitment
Estonia Germany Hungary Latvia Lithuania
Contacts
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Affiliation: 
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Key inclusion & exclusion criteria
Inclusion criteria:
- Signed informed consent
- Men or women aged 18 to 75 years
- Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology
- Patient being in remission, defined as: Clinical Activity Index (CAI) <= 4 and Endoscopic Index (EI) < 4
- Extent of inflammation during last acute episode was >= 15 cm beyond the anal margin
- Last acute episode ended within 3 months prior to study entry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Crohn’s disease,
2) Prior bowel resection leading to diarrhoea and/or pouch formation,
3) Toxic megacolon,
4) Gastric or duodenal ulcer,
5) Haemorrhagic diathesis,
6) Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding
haemorrhoids or hiatal hernia),
7) Active colorectal cancer or a history of colorectal cancer,
8) Serious other secondary illnesses of an acute or chronic nature,
9) Asthma,
10) Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per
1.73 m 2 ,
11) Serum transaminase (ALT and/or AST) and/or alkaline phosphatase >=2x ULN,
12) Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous
[IV] or topical rectal) within 30 days prior to baseline,
13) Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment (i.e.
> 6 weeks), other than acetylsalicylic acid (<=350 mg/day), or paracetamol,
14) Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other
constituents of the study drugs,
15) Well-founded doubt about the patient’s cooperation,
16) Existing or intended pregnancy, breast-feeding,
17) Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal
contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a
condom and spermicide), partner has undergone vasectomy and subject is in monogamous
relationship. The investigator is responsible for determining whether the subject has adequate
birth control for study participation,
18) Participation in another clinical trial (except SAF-6/UCA or SAG-26/UCA) within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Maintenance therapy of ulcerative colitis
Intervention(s)

Trade Name: Salofalk® 500mg Granu-Stix®
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use

Product Name: 1500mg mesalazine pellets
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1500-

Product Name: 750mg mesalazine pellets
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 750-

Product Name: 250mg mesalazine pellets
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)
Primary end point(s): clinical remission at the final/withdrawal visit, with clinical relapse being defined as CAI > 4 and an increase of >= 3 points from baseline
Main Objective: To proof the therapeutic equivalence of once daily (OD) versus tree times daily (TID) dosing of total 1.5 g mesalazine for remission maintenance and to evaluate whether 3 g OD is superior to 0.5 g TID mesalazine for remission maintenance in patients with ulcerative colitis
Secondary Objective: - To study safety and tolerability in the form of adverse events and laboratory parameters
- To assess patients' preference regarding dosing schedule
- To assess patients' quality of life
Secondary Outcome(s)
Secondary ID(s)
2004-001218-15-DE
not available
SAG-27/UCR
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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