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

Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis

Intervention: mesalazine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dr. Falk Pharma GmbH

Official(s) and/or principal investigator(s):
Wolfgang Kruis, Professor, Principal Investigator, Affiliation: Evangelisches Krankenhaus Kalk, Cologne, Germany

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Rate of clinical remission

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Evangelisches Krankenhaus Kalk, Cologne 51103, Germany
Additional Information

Starting date: July 2005
Last updated: March 20, 2007

Page last updated: August 23, 2015

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