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Completed

NCT Number: NCT00449722

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Evangelisches Krankenhaus Kalk

Cologne, 51103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalazine

Drug

Primary outcomes

  1. Rate of clinical remission

Secondary outcomes

  1. Rate of clinical response

  2. time to resolution of symptoms

  3. rate of endoscopical remission

  4. rate of endoscopical response

  5. rate of histological remission

  6. rate of histological response

  7. PGA

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Mar 21, 2007
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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