Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC

• Conditions: Therapy of active ulcerative colitis; MedDRA version: 7.1Level: LLTClassification code 10058816

• Registration Number: EUCTR2004-001216-31-SI
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-26
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

- Signed informed consent
- Men or women aged 18 to 75 years
- Active ulcerative colitis except proctitis, i.e. inflammation minimal 15 cm ab ano, confirmed by endoscopy and histology
- Established or new diagnosis
- Disease activity at baseline:
Clinical Activity Index (CAI) > 4 and Endoscopic Index (EI) >=4
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

- Crohn's disease,
- Prior bowel resection leading to diarrhoea and/or pouch formation,
- Toxic megacolon,
- Gastric or duodenal ulcer,
- Haemorrhagic diathesis,
- Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding haemorrhoids or hiatal hernia),
- Active colorectal cancer or a history of colorectal cancer,
- Serious other secondary illnesses of an acute or chronic nature,
- Asthma,
- Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2,
- Serum transaminase (ALT and/or AST) and/or alkaline phosphatase >= 2x ULN,
- Baseline stool positive for germs causing bowel disease,
- Current relapse occurred under maintenance treatment with > 2.0 g/day mesalazine or > 3.0 g/day sulfasalazine,
- Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to baseline,
- Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment; permitted is acetylsalicylic acid (<= 350 mg/day) and paracetamol,
- Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
- Well-founded doubt about the patient’s cooperation,
- Existing or intended pregnancy, breast-feeding,
- 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,
- Participation in another clinical trial 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