TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

Dr. Falk Pharma GmbH306 enrolled

Overview

The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

306

Conditions

Active Ulcerative Colitis

Interventions

Mesalazine - TID 1000 mgDRUG

Mesalazine - TID 2x 500 mgDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Men or women aged 18 to 75 years * Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology Exclusion Criteria: * Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis) * Toxic megacolon * Screening stool positive for germs causing bowel disease * Malabsorption syndromes * Celiac disease * Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding

Locations (1)

Med. Klinik 1 - Markus-Krankenhaus

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

Rate of clinical remission

Proportion of patients with clinical remission at week 8 compared to baseline. Clinical remission includes normalisation of stool frequency and absence of blood in stools

Time frame: 8 weeks

Secondary Outcomes

Number of stools per week

Time frame: 8 weeks

Number of bloody stools per week

Time frame: 8 weeks

Time to first resolution of clinical symptoms

Times to first resolution of symptoms defined as the periods from the day of first administration of trial medication , until the * First of at least 3 consecutive days each with =\< 3 stools/day * First of at least 3 consecutive days each with no bloody stools/day, * First of at least 3 consecutive days each with =\< 3 stools/day, all without blood

Time frame: 8 weeks

Data from ClinicalTrials.gov

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