OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449722
• Other study ID #: SAG-26/UCA
• Secondary ID: 2004-001216-31
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: January 20, 2016
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: January 2016
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria (main):

• 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

Exclusion Criteria (main):

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• mesalazine

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Kalk	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kruis W, Kiudelis G, Rácz 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission
Secondary	Rate of clinical response
Secondary	time to resolution of symptoms
Secondary	rate of endoscopical remission
Secondary	rate of endoscopical response
Secondary	rate of histological remission
Secondary	rate of histological response
Secondary	PGA