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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:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2004-001218-15-LV |
Date of registration:
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30/05/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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30/05/2005 |
Target sample size:
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510 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001218-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Estonia
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Germany
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Hungary
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Latvia
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Lithuania
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Key inclusion & exclusion criteria
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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.
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Maintenance therapy of ulcerative colitis
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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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
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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
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Secondary ID(s)
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2004-001218-15-DE
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not available
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SAG-27/UCR
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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