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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 Development LLC
ClinicalTrials.gov Identifier:
NCT00151944
First received: September 7, 2005
Last updated: June 26, 2009
Last verified: December 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
FDA Recall information  This link exits the ClinicalTrials.gov site
FDA Medical Product Safety Alerts  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00151944     History of Changes
Other Study ID Numbers: SPD476-303
Study First Received: September 7, 2005
Last Updated: June 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013