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Clinical Trials/EUCTR2004-000734-36-CZ
EUCTR2004-000734-36-CZ
Active, not recruiting
Phase 1

A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.

Shire Pharmaceutical Development Inc.0 sites125 target enrollmentOctober 8, 2004
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ConditionsSubject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study
Sponsor
Shire Pharmaceutical Development Inc.
Enrollment
125
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 8, 2004
End Date
March 13, 2006
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Shire Pharmaceutical Development Inc.

Eligibility Criteria

Inclusion Criteria

  • •Subjects must sign the study 303 informed consent form, meet all eligibility requirements and have completed all assessments of the Study 301 or 302 End of Study /Early Withdrawal Visit.
  • •Women of child bearing potential (WOP) must use an acceptable contraceptive method while the subject is on the study treatment.
  • •Subject and investigator must egree that participation in the Acute and/or Maintenance Phase of this study is in the best interest of the subject
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Subject who have withdrawn from Study 301 or 302 before study visit 3, or subject who withdrew from Study 301 or 302 due to a possibly or probably related severe AE or SAE are not eligible to enter this study.

Outcomes

Primary Outcomes

Not specified

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