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
- Conditions
- Maintenance therapy of ulcerative colitis
- Registration Number
- EUCTR2004-001218-15-LT
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
- 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method