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

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00545389
First received: October 16, 2007
Last updated: June 18, 2009
Last verified: November 2007
History of Changes

October 16, 2007
June 18, 2009
February 2003
Not Provided
% of subjects in remission (UC-DAI score) [ Time Frame: Week 8 ]
Same as current
Complete list of historical versions of study NCT00545389 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA [ Time Frame: 8 weeks ]
  • Safety and tolerability [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
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

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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colitis, Ulcerative
Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
Other Name: LIALDA
Not Provided
D'Haens G, Hommes D, Engels L, Baert F, van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1087-97.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00545389
SPD476-202
Not Provided
Not Provided
Shire Development LLC
Not Provided
Principal Investigator: Prof Dr Geert D'Haens Imelda General Hospital, Belgium
Shire Development LLC
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP