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

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SPD476 (mesalazine)
Sponsored by
Shire
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Treatment emergent adverse events

    Secondary Outcome Measures

    Time to relapse
    Participant compliance
    Number of participants in remission
    Ulcerative colitis disease activity index (UC-DAI) score
    Patient questionnaire

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    June 21, 2021
    Sponsor
    Shire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00151944
    Brief Title
    Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 26, 2003 (Actual)
    Primary Completion Date
    March 13, 2006 (Actual)
    Study Completion Date
    March 13, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shire

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colitis, Ulcerative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SPD476 (mesalazine)
    Primary Outcome Measure Information:
    Title
    Treatment emergent adverse events
    Time Frame
    Throughout the study period of approximately 2 year, 4 months
    Secondary Outcome Measure Information:
    Title
    Time to relapse
    Time Frame
    Up to 12-14 months
    Title
    Participant compliance
    Time Frame
    Up to 12-14 months
    Title
    Number of participants in remission
    Time Frame
    12 months
    Title
    Ulcerative colitis disease activity index (UC-DAI) score
    Time Frame
    Baseline, Month 2, and Month 12
    Title
    Patient questionnaire
    Time Frame
    Month 6, and Month 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18272546
    Citation
    Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Jul;57(7):893-902. doi: 10.1136/gut.2007.138248. Epub 2008 Feb 13.
    Results Reference
    result
    PubMed Identifier
    18671232
    Citation
    Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009 Jan;15(1):1-8. doi: 10.1002/ibd.20580.
    Results Reference
    result
    Links:
    URL
    http://www.fda.gov/opacom/7alerts.html
    Description
    FDA Recall information
    URL
    http://www.lialda.com/Professional/pdf/pi.pdf
    Description
    FDA-approved labelling information, US only

    Learn more about this trial

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

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