search
Back to results

OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
mesalazine
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (main):

  • Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
  • Established or new diagnosis
  • Disease activity at baseline: Clinical Activity Index (CAI) >4 and Endoscopic Index (EI) >= 4

Exclusion Criteria (main):

  • Crohn's disease
  • Toxic megacolon
  • Present or past colorectal cancer
  • Symptomatic gastrointestinal disease
  • Serious secondary disease(s)
  • Baseline stool positive for germs causing bowel disease
  • Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
  • Current relapse occurred under maintenance treatment with >2g/day mesalazine
  • Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2
  • Serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x ULN

Sites / Locations

  • Evangelisches Krankenhaus Kalk

Outcomes

Primary Outcome Measures

Rate of clinical remission

Secondary Outcome Measures

Rate of clinical response
time to resolution of symptoms
rate of endoscopical remission
rate of endoscopical response
rate of histological remission
rate of histological response
PGA

Full Information

First Posted
March 20, 2007
Last Updated
January 20, 2016
Sponsor
Dr. Falk Pharma GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00449722
Brief Title
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
Official Title
Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
380 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
mesalazine
Primary Outcome Measure Information:
Title
Rate of clinical remission
Secondary Outcome Measure Information:
Title
Rate of clinical response
Title
time to resolution of symptoms
Title
rate of endoscopical remission
Title
rate of endoscopical response
Title
rate of histological remission
Title
rate of histological response
Title
PGA

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 (main): Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology Established or new diagnosis Disease activity at baseline: Clinical Activity Index (CAI) >4 and Endoscopic Index (EI) >= 4 Exclusion Criteria (main): Crohn's disease Toxic megacolon Present or past colorectal cancer Symptomatic gastrointestinal disease Serious secondary disease(s) Baseline stool positive for germs causing bowel disease Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline Current relapse occurred under maintenance treatment with >2g/day mesalazine Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2 Serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kruis, Professor
Organizational Affiliation
Evangelisches Krankenhaus Kalk, Cologne, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evangelisches Krankenhaus Kalk
City
Cologne
ZIP/Postal Code
51103
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18832520
Citation
Kruis W, Kiudelis G, Racz I, Gorelov IA, Pokrotnieks J, Horynski M, Batovsky M, Kykal J, Boehm S, Greinwald R, Mueller R; International Salofalk OD Study Group. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009 Feb;58(2):233-40. doi: 10.1136/gut.2008.154302. Epub 2008 Oct 2.
Results Reference
result

Learn more about this trial

OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

We'll reach out to this number within 24 hrs