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

Phase 3

Completed

• Conditions: Active Ulcerative Colitis
• Interventions: Drug: Mesalazine - TID 1000 mg; Drug: Mesalazine - TID 2x 500 mg

• Registration Number: NCT01745770
• Lead Sponsor: Dr. Falk Pharma GmbH

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Study Start: 2013-01
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-30
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Mesalazine - TID 1000 mg	-
B	Mesalazine - TID 2x 500 mg	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of bloody stools per week	8 weeks
Number of stools per week	8 weeks

Trial Locations

Locations (1)

Med. Klinik 1 - Markus-Krankenhaus; 🇩🇪 Frankfurt, Hessen, Germany