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OpenTrials
Completed

NCT Number: NCT01745770

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

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

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Key information

Conditions

Active Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Med. Klinik 1 - Markus-Krankenhaus

Frankfurt am Main, Hesse, 60431, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalazine - TID 1000 mg

Drug

Mesalazine - TID 2x 500 mg

Drug

Primary outcomes

  1. Rate of clinical remission

    Time frame: 8 weeks

    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

Secondary outcomes

  1. Number of stools per week

    Time frame: 8 weeks

  2. Number of bloody stools per week

    Time frame: 8 weeks

  3. Time to first resolution of clinical symptoms

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study title

Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2012
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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