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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
First received: December 5, 2012
Last updated: March 23, 2015
Last verified: March 2015
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:

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 2015
Estimated Primary Completion Date: March 2015 (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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01745770

Med. Klinik 1 - Markus-Krankenhaus
Frankfurt, Hessen, Germany, 60431
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: March 23, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on February 11, 2016