Multicentre, controlled, randomised, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS (MOTUS study)

Phase 3

Completed

Conditions: IBD
ulcerative colitis
10017943

Registration Number: NL-OMON32538

Lead Sponsor: Ferring

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

• Male and female patients, aged over 18 years.
• Active mild to moderate ulcerative colitis (new or relaps) with disease extension beyond rectum
• at least one total colonoscopy in their disease history (within the previous 5 years.
• UC-DAI score 3-8.
• Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
• Oral maintenance treatment with azathioprine or 6-mercaptopurine (taken for at least 6 months at stable dose and continued at the same dose throughout the study) is permitted.

Exclusion Criteria

• Previous colonic surgery.
• Previously failed to respond to steroids within the previous year.
• Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose > 3/day for induction of remission within the previous year.
• Current relapse lasting more than 6 weeks.
• Pregnancy or breast-feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Remission at week 8.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Compliance<br /><br>• Clinical remission at week 4 and week 8<br /><br>• Clinical variables improvement (stool frequency and bloody stools) at week 4,<br /><br>8 and 12 separately<br /><br>• Treatment failure rates at W4 and W8<br /><br>• Time to remission according patient*s diary (normal stool frequency and<br /><br>cessation of bleeding)<br /><br>• Time to cessation of bleeding<br /><br>• Improvement at week 4 and 8 based on UC-DAI score<br /><br>• Endoscopic assessment at W0 and W8<br /><br>• Acceptability of the treatment<br /><br>• Safety<br /><br>• Proportion of patients staying in clinical remission at week 12.</p><br>