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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00151944
First received: September 7, 2005
Last updated: June 6, 2014
Last verified: December 2008

September 7, 2005
June 6, 2014
November 2003
Not Provided
Treatment emergent adverse events over 12 months.
Same as current
Complete list of historical versions of study NCT00151944 on ClinicalTrials.gov Archive Site
  • Time to relapse
  • Subject compliance
  • Number of subjects in remission after 12 months
  • UC-DAI score
  • Patient questionnaire
Same as current
Not Provided
Not Provided
 
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colitis, Ulcerative
Drug: SPD476 (mesalazine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
October 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00151944
SPD476-303, 2004-000734-36
Not Provided
Not Provided
Shire
Not Provided
Not Provided
Shire
December 2008

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