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

June 21, 2021 updated by: Shire

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.

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

Study Overview

Status

Completed

Conditions

Colitis, Ulcerative

Intervention / Treatment

Drug: SPD476 (mesalazine)

Study Type

Interventional

Enrollment

400

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment emergent adverse events Time Frame: Throughout the study period of approximately 2 year, 4 months	Throughout the study period of approximately 2 year, 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to relapse Time Frame: Up to 12-14 months	Up to 12-14 months
Participant compliance Time Frame: Up to 12-14 months	Up to 12-14 months
Number of participants in remission Time Frame: 12 months	12 months
Ulcerative colitis disease activity index (UC-DAI) score Time Frame: Baseline, Month 2, and Month 12	Baseline, Month 2, and Month 12
Patient questionnaire Time Frame: Month 6, and Month 12	Month 6, and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2003

Primary Completion (Actual)

March 13, 2006

Study Completion (Actual)