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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745770
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: Mesalazine - TID 1000 mg
Active Comparator: B Drug: Mesalazine - TID 2x 500 mg

Primary Outcome Measures :
  1. Rate of clinical remission [ Time Frame: 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 :
  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 [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745770

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Med. Klinik 1 - Markus-Krankenhaus
Frankfurt, Hessen, Germany, 60431
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01745770    
Other Study ID Numbers: SAT-25/UCA
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents