Back to resultsTID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
Primary Purpose
Active Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Mesalazine - TID 1000 mg
Mesalazine - TID 2x 500 mg
Sponsored by
About this trial
This is an interventional treatment trial for Active Ulcerative Colitis
Eligibility 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
Sites / Locations
- Med. Klinik 1 - Markus-Krankenhaus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of stools per week
Number of bloody stools per week
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01745770
Brief Title
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mesalazine - TID 1000 mg
Intervention Type
Drug
Intervention Name(s)
Mesalazine - TID 2x 500 mg
Primary Outcome Measure Information:
Title
Rate of clinical remission
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of stools per week
Time Frame
8 weeks
Title
Number of bloody stools per week
Time Frame
8 weeks
Title
Time to first resolution of clinical symptoms
Description
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
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Med. Klinik 1 - Markus-Krankenhaus
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60431
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
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