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Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Mesalazine

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

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

Inclusion Criteria:

newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of => 1 and a PGA <=2) with compatible histology
females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception

Exclusion Criteria:

subjects with relapsing UC who were in relapse for > 6 weeks prior to baseline
subjects who relapsed on maintenace therapy with doses of mesalazine => 2g/day
subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of > 2g/day
subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment

Sites / Locations

Imelda General Hospital Dept of Gastroenterology

Outcomes

Primary Outcome Measures

Percentage of subjects in remission (UC-DAI score <=1, with scores of 0 for rectal bleeding and stool frequency and a sigmoidoscopy score reduction of 1 point or more from baseline)

Secondary Outcome Measures

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

Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA

Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score

Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score

Full Information

NCT ID

NCT00548574

First Posted

October 23, 2007

Last Updated

June 8, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT00548574

Brief Title

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Official Title

A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

December 4, 2003 (Actual)

Primary Completion Date

October 20, 2004 (Actual)

Study Completion Date

October 20, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo

6. Conditions and Keywords

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

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

343 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Other Intervention Name(s)

LIALDA

Intervention Type

Drug

Intervention Name(s)

Mesalazine

Other Intervention Name(s)

ASACOL

Primary Outcome Measure Information:

Title

Percentage of subjects in remission (UC-DAI score <=1, with scores of 0 for rectal bleeding and stool frequency and a sigmoidoscopy score reduction of 1 point or more from baseline)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

8 weeks

Title

Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA

Time Frame

8 weeks

Title

Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score

Time Frame

8 weeks

Title

Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of => 1 and a PGA <=2) with compatible histology females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception Exclusion Criteria: subjects with relapsing UC who were in relapse for > 6 weeks prior to baseline subjects who relapsed on maintenace therapy with doses of mesalazine => 2g/day subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of > 2g/day subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Imelda General Hospital Dept of Gastroenterology

City

Bonheiden

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

17241860

Citation

Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.

Results Reference

result

Links:

URL

http://www.lialda.com/Professional/pdf/pi.pdf

Description

FDA-approved labelling information, US only

URL

http://www.fda.gov/opacom/7alerts.html

Description

FDA Recall information

Learn more about this trial

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

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