Skip to main content
OpenTrials
Completed

NCT Number: NCT00545389

Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Imelda General Hospital

Bonheiden, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
  • general medical assessment satisfactory and no clinically significant and relevant abnormalities

Exclusion criteria

  • severe ulcerative colitis
  • subject in relapse for > 6 weeks
  • use of systemic or rectal steroids within last 4 weeks prior to baseline
  • subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
  • subjects hypersensitive to salicylates/aspirin
  • subjects with moderate or severe renal impairment

Treatment and study plan

SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Drug

Other names: LIALDA

Primary outcomes

  1. % of subjects in remission (UC-DAI score)

    Time frame: Week 8

Secondary outcomes

  1. Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology

    Time frame: 8 weeks

  2. Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA

    Time frame: 8 weeks

  3. Safety and tolerability

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 17, 2007
Registry last updated
Jun 11, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.