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

Active Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745770
• Other study ID #: SAT-25/UCA
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2012
• Last updated: May 30, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Ulcerative Colitis
• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Mesalazine - TID 1000 mg

• Mesalazine - TID 2x 500 mg

Locations

Country	Name	City	State
Germany	Med. Klinik 1 - Markus-Krankenhaus	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks	No
Secondary	Number of stools per week		8 weeks	No
Secondary	Number of bloody stools per week		8 weeks	No
Secondary	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	8 weeks	No