Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.

Colitis, Ulcerative Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151944
• Other study ID #: SPD476-303
• Secondary ID: 2004-000734-36
• Status: Completed
• Phase: Phase 3
• Start date: November 26, 2003
• Est. completion date: March 13, 2006

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 13, 2006
• Est. primary completion date: March 13, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• SPD476 (mesalazine)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

References & Publications (2)

Kamm 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. — View Citation

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events		Throughout the study period of approximately 2 year, 4 months
Secondary	Time to relapse		Up to 12-14 months
Secondary	Participant compliance		Up to 12-14 months
Secondary	Number of participants in remission		12 months
Secondary	Ulcerative colitis disease activity index (UC-DAI) score		Baseline, Month 2, and Month 12
Secondary	Patient questionnaire		Month 6, and Month 12

External Links

•   FDA Recall information
•   FDA-approved labelling information, US only