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

This study is currently recruiting participants.
Verified April 2013 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01745770
First received: December 5, 2012
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Active Ulcerative Colitis
 Drug: Mesalazine - TID 1000 mg
Drug: Mesalazine - TID 2x 500 mg
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of clinical remission [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Number of stools per week [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Number of bloody stools per week [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time to first resolution of clinical symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Mesalazine - TID 1000 mg
Active Comparator: B Drug: Mesalazine - TID 2x 500 mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745770

Contacts
Contact: Tanju Nacak, Dr. +49 (0)761 1514 ext 187 nacak@drfalkpharma.de
Contact: Axel Dignaß, Prof. Dr. +49 (0)69 953322 ext 01 axel.dignass@fdk.info

Locations
Germany
Med. Klinik 1 - Markus-Krankenhaus Recruiting
Frankfurt, Hessen, Germany, 60431
Contact: Axel Dignaß, Prof. Dr.     +49 (0)69 953322 ext 01     axel.dignass@fdk.info    
Principal Investigator: Axel Dignaß, Prof. Dr.            
Sponsors and Collaborators
Dr. Falk Pharma GmbH
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01745770     History of Changes
Other Study ID Numbers: SAT-25/UCA
Study First Received: December 5, 2012
Last Updated: April 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013