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

This study has been completed.
Information provided by:
Shire Identifier:
First received: September 7, 2005
Last updated: June 6, 2014
Last verified: December 2008
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.

Condition Intervention Phase
Colitis, Ulcerative
Drug: SPD476 (mesalazine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Treatment emergent adverse events over 12 months.

Secondary Outcome Measures:
  • Time to relapse
  • Subject compliance
  • Number of subjects in remission after 12 months
  • UC-DAI score
  • Patient questionnaire

Estimated Enrollment: 400
Study Start Date: November 2003
Study Completion Date: October 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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  More Information

Additional Information:
Publications: Identifier: NCT00151944     History of Changes
Other Study ID Numbers: SPD476-303
2004-000734-36 ( EudraCT Number )
Study First Received: September 7, 2005
Last Updated: June 6, 2014

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 24, 2017