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

Colitis, Ulcerative Clinical Trial

Official title:

Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746447
• Other study ID #: SAG-27/UCR
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2008
• Last updated: June 25, 2012
• Start date: May 2005
• Est. completion date: March 2008

Study information

• Verified date: June 2012
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: March 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Recurrence
• Ulcer

Intervention

Drug:
• mesalamine granules
3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
• mesalamine granules
1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
• mesalamine granules
0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Kalk, Medical Dept.	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Bátovský M, Lozynsky YS, Zakharash Y, Rácz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group. Randomised clinical trial: a comparative dose — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to relapse		within 52 weeks	No
Secondary	Proportion of patients in endoscopical remission, defined as a mucosal appearance score of = 1 at final/withdrawal examination.		week 52 or premature withdrawal	No