Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

Phase 3

Completed

• Conditions: Colitis, Ulcerative; Recurrence
• Interventions: Drug: mesalamine granules

• Registration Number: NCT00746447
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-04
• Study Completion: 2008-03
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 648

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 (according to Rachmilewitz) 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.

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Exclusion Criteria

• Crohn's disease,
• Prior bowel resection leading to diarrhoea,
• Toxic megacolon,
• Gastric or duodenal ulcer,
• Haemorrhagic diathesis,
• Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia),
• Active colorectal cancer or a history of colorectal cancer,
• Serious other secondary illnesses of an acute or chronic nature,
• Asthma,
• Severe impairment of renal (e.g., serum creatinine > 1.5 mg/dl) and/or liver functions (e.g., serum transaminase [ALT and/or AST] or alkaline phosphatase >=2x upper limit of normal [ULN]),
• 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 (i.e. > 6 weeks), other than acetylsalicylic acid (<= 350 mg/day), or 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.5g OD	mesalamine granules	-
0.5g TID	mesalamine granules	-
3.0g OD	mesalamine granules	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline.	week 52 or premature withdrawal

Secondary Outcome Measures

Name	Time	Method
Time to relapse	within 52 weeks
Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination.	week 52 or premature withdrawal

Trial Locations

Locations (1)

Evangelisches Krankenhaus Kalk, Medical Dept.; 🇩🇪 Cologne, Germany