OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: mesalazine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Dr. Falk Pharma GmbH Official(s) and/or principal investigator(s): Wolfgang Kruis, Professor, Principal Investigator, Affiliation: Evangelisches Krankenhaus Kalk, Cologne, Germany
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Rate of clinical remission
Secondary outcome: Rate of clinical responsetime to resolution of symptoms rate of endoscopical remission rate of endoscopical response rate of histological remission rate of histological response PGA
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Evangelisches Krankenhaus Kalk, Cologne 51103, Germany
Additional Information
Starting date: July 2005
Last updated: March 20, 2007
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