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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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mesalazine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No