NCT00503243

Brief Summary

The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily (\[BID\] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

July 16, 2007

Last Update Submit

June 8, 2021

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline

    8 weeks

Secondary Outcomes (5)

  • Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score

    8 weeks

  • Change in the UC-DAI score

    8 weeks

  • Change in symptoms (rectal bleeding and stool frequency)

    2, 4 and 8 weeks

  • Change in sigmoidoscopic (mucosal) appearance

    8 weeks

  • Time to withdrawal from the start of study medication

    Throughout the study period of 8 weeks

Interventions

Delayed and extended release mesalazineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed or diagnosis of relapsing (relapsed \<= 6 weeks to baseline) mild to moderate ulcerative colitis
  • women not of childbearing potential or WOCP who agreed to use an effective contraceptive method

You may not qualify if:

  • severe ulcerative colitis or relapsed for \> 6 weeks prior to baseline
  • subjects who had relapsed on maintenance therapy with doses of mesalazine \> 2.0 g/day
  • subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
  • subjects with asthma if they were known to be mesalazine-sensitive
  • subjects who were at immediate or significant risk of toxic megacolon
  • subjects who had previous resective colonic surgery
  • subjects who had moderate or severe renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

  • Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, Butler T, Lees K, Joseph RE, Sandborn WJ. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007 Jan;5(1):95-102. doi: 10.1016/j.cgh.2006.10.025.

    PMID: 17234558RESULT

Related Links

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

September 30, 2003

Primary Completion

January 17, 2005

Study Completion

January 17, 2005

Last Updated

June 11, 2021

Record last verified: 2021-06

Locations

US(1)