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Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.

NCT00737789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2015-03-04

No results posted yet for this study

Summary

The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

Conditions

Interventions

DRUG

Mesalazine slow-release granules

Mesalazine 2g Sachet prolonged release granules, administered orally.

DRUG

Mesalazine liquid enema

1g mesalazine liquid enema, administered topically once a day in the evening.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Belgium
  • France
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737789 on ClinicalTrials.gov