Not Signed In -
Ulcerative Colitis |
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Clinical Trial: Safety and Tolerability of SPD476 in Maintaining Remission in Patients with Ulcerative Colitis.
This study is no longer recruiting patients.
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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 III |
MedlinePlus related topics: Ulcerative Colitis
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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.
Further Study Details:
Primary Outcomes: Treatment emergent adverse events over 12 months.
Secondary Outcomes: Time to relapse; Subject compliance; Number of subjects in remission after 12 months; UC-DAI score; Patient questionnaire
Expected Total Enrollment: 400
Secondary Outcomes: Time to relapse; Subject compliance; Number of subjects in remission after 12 months; UC-DAI score; Patient questionnaire
Expected Total Enrollment: 400
Study start: November 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
More Information
Study ID Numbers: SPD476-303
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00151944
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00151944
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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