Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
2 other identifiers
interventional
400
0 countries
N/A
Brief Summary
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2003
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2006
CompletedJune 23, 2021
June 1, 2021
2.3 years
September 7, 2005
June 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment emergent adverse events
Throughout the study period of approximately 2 year, 4 months
Secondary Outcomes (5)
Time to relapse
Up to 12-14 months
Participant compliance
Up to 12-14 months
Number of participants in remission
12 months
Ulcerative colitis disease activity index (UC-DAI) score
Baseline, Month 2, and Month 12
Patient questionnaire
Month 6, and Month 12
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
- Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
- Women of childbearing potential must use an acceptable contraceptive method while on study treatment
You may not qualify if:
- Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Related Publications (2)
Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Jul;57(7):893-902. doi: 10.1136/gut.2007.138248. Epub 2008 Feb 13.
PMID: 18272546RESULTKamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009 Jan;15(1):1-8. doi: 10.1002/ibd.20580.
PMID: 18671232RESULT
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 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
November 26, 2003
Primary Completion
March 13, 2006
Study Completion
March 13, 2006
Last Updated
June 23, 2021
Record last verified: 2021-06