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
1 other identifier
interventional
38
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2004
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedJune 11, 2021
June 1, 2021
1.7 years
October 16, 2007
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
% of subjects in remission (UC-DAI score)
Week 8
Secondary Outcomes (3)
Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology
8 weeks
Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA
8 weeks
Safety and tolerability
8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
Imelda General Hospital
Bonheiden, Belgium
Related Publications (1)
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. doi: 10.1111/j.1365-2036.2006.03082.x.
PMID: 16984503RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
February 10, 2003
Primary Completion
October 20, 2004
Study Completion
October 20, 2004
Last Updated
June 11, 2021
Record last verified: 2021-06