NCT00946946

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe endoscopic recurrence.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Azathioprine	2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
DRUG	Mesalazine	4g Mesalazine tablets/day AND azathioprine placebo tablets
DRUG	Azathioprine placebo	4g Mesalazine tablets/day AND azathioprine placebo tablets
DRUG	Mesalazine placebo	2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

Timeline

• Start date: 2002-02-01
• Primary completion: 2007-05-01
• Completion: 2009-07-01
• First posted: 2009-07-27
• Last updated: 2012-06-26

Locations

2 sites across 2 countries: Austria, Germany