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CompletedNCT01745770Updated Jun 1, 2016

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

A Phase 3 interventional study of Mesalazine - TID 1000 mg and Mesalazine - TID 2x 500 mg in Active Ulcerative Colitis, sponsored by Dr. Falk Pharma GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-01.

Sponsored by Dr. Falk Pharma GmbH · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Active Ulcerative Colitis
03

In context

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
306 participants (actual)

Study arms

  • Experimental
    A

    Drug: Mesalazine - TID 1000 mg

  • Active comparator
    B

    Drug: Mesalazine - TID 2x 500 mg

Interventions

  • DrugMesalazine - TID 1000 mg
  • DrugMesalazine - TID 2x 500 mg
06

What researchers measure

Primary outcomes

  1. 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

  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

    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

07

Study locations

1 site
  • Med. Klinik 1 - Markus-Krankenhaus
    Frankfurt am Main, Hesse 60431, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01745770
Lead sponsor
Dr. Falk Pharma GmbH
Responsible party
Sponsor
First posted
Dec 10, 2012
Start date
Jan 2013
Primary completion
Mar 2015
Completion
Jun 2015
Last update
Jun 1, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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