OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
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
2 other identifiers
interventional
380
1 country
1
Brief Summary
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2005
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 20, 2007
CompletedFirst Posted
Study publicly available on registry
March 21, 2007
CompletedJanuary 21, 2016
January 1, 2016
March 20, 2007
January 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of clinical remission
Secondary Outcomes (7)
Rate of clinical response
time to resolution of symptoms
rate of endoscopical remission
rate of endoscopical response
rate of histological remission
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm 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
You may not qualify if:
- Crohn's disease
- Toxic megacolon
- Present or past colorectal cancer
- Symptomatic gastrointestinal disease
- Serious secondary disease(s)
- Baseline stool positive for germs causing bowel disease
- Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
- Current relapse occurred under maintenance treatment with \>2g/day mesalazine
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evangelisches Krankenhaus Kalk
Cologne, 51103, Germany
Related Publications (1)
Kruis W, Kiudelis G, Racz I, Gorelov IA, Pokrotnieks J, Horynski M, Batovsky M, Kykal J, Boehm S, Greinwald R, Mueller R; International Salofalk OD Study Group. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009 Feb;58(2):233-40. doi: 10.1136/gut.2008.154302. Epub 2008 Oct 2.
PMID: 18832520RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Kruis, Professor
Evangelisches Krankenhaus Kalk, Cologne, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2007
First Posted
March 21, 2007
Study Start
July 1, 2005
Study Completion
June 1, 2006
Last Updated
January 21, 2016
Record last verified: 2016-01