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

NCT00746447 | Completed Phase 3

• 2 other identifiers: SAG-27/UCREudraCT No.: 2004-001218-15
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

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

Conditions

Colitis, Ulcerative; Recurrence

Keywords

maintenance; 5-ASA; mesalamine; mesalazine; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

3.0g OD

EXPERIMENTAL

Drug: mesalamine granules

1.5g OD

EXPERIMENTAL

Drug: mesalamine granules

0.5g TID

ACTIVE COMPARATOR

Drug: mesalamine granules

Interventions

mesalamine granules DRUG

3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;

Also known as: Salofalk granules, Mesalazine

3.0g OD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Dr. Falk Pharma GmbH: lead

Study Sites (1)

Evangelisches Krankenhaus Kalk, Medical Dept.

Cologne, 51103, Germany

Location

Related Publications (1)

• Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Batovsky M, Lozynsky YS, Zakharash Y, Racz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group. Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. Aliment Pharmacol Ther. 2011 Feb;33(3):313-22. doi: 10.1111/j.1365-2036.2010.04537.x. Epub 2010 Dec 8.

  PMID: 21138455 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Recurrence

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Ralph Mueller, Dr.

  Dr. Falk Pharma GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: May 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: March 1, 2008
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

DE (1)