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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01745770

Enrollment

306

Registered

2012-12-10

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Ulcerative Colitis

Brief 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

Interventions

DRUGMesalazine - TID 1000 mg

DRUGMesalazine - TID 2x 500 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of clinical remission	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

Measure	Time frame	Description
Number of stools per week	8 weeks	—
Number of bloody stools per week	8 weeks	—
Time to first resolution of clinical symptoms	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026