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OpenTrials
Completed

NCT Number: NCT00151944

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

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

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPD476 (mesalazine)

Drug

Primary outcomes

  1. Treatment emergent adverse events

    Time frame: Throughout the study period of approximately 2 year, 4 months

Secondary outcomes

  1. Time to relapse

    Time frame: Up to 12-14 months

  2. Participant compliance

    Time frame: Up to 12-14 months

  3. Number of participants in remission

    Time frame: 12 months

  4. Ulcerative colitis disease activity index (UC-DAI) score

    Time frame: Baseline, Month 2, and Month 12

  5. Patient questionnaire

    Time frame: Month 6, and Month 12

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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