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CompletedNCT00151944Updated Jun 23, 2021

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

A Phase 3 interventional study of SPD476 (mesalazine) in Colitis, Ulcerative, sponsored by Shire. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by Shire · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Nov 2003, registered Sep 2005).
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Colitis, Ulcerative
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 400 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants

Interventions

  • DrugSPD476 (mesalazine)
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18272546 ↗
  • 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. PubMed 18671232 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00151944
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Sep 9, 2005
Start date
Nov 26, 2003
Primary completion
Mar 13, 2006
Completion
Mar 13, 2006
Last update
Jun 23, 2021

Study contacts

Study Director
study director · Takeda
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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