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Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

Primary Purpose

Colitis, Ulcerative

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

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

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:

male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
general medical assessment satisfactory and no clinically significant and relevant abnormalities

Exclusion Criteria:

severe ulcerative colitis
subject in relapse for > 6 weeks
use of systemic or rectal steroids within last 4 weeks prior to baseline
subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
subjects hypersensitive to salicylates/aspirin
subjects with moderate or severe renal impairment

Sites / Locations

Imelda General Hospital

Outcomes

Primary Outcome Measures

% of subjects in remission (UC-DAI score)

Secondary Outcome Measures

Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology

Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA

Safety and tolerability

Full Information

NCT ID

NCT00545389

First Posted

October 16, 2007

Last Updated

June 8, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT00545389

Brief Title

Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

Official Title

A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 10, 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

5. Study Description

Brief Summary

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (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

Primary Outcome Measure Information:

Title

% of subjects in remission (UC-DAI score)

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology

Time Frame

8 weeks

Title

Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA

Time Frame

8 weeks

Title

Safety and tolerability

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis general medical assessment satisfactory and no clinically significant and relevant abnormalities Exclusion Criteria: severe ulcerative colitis subject in relapse for > 6 weeks use of systemic or rectal steroids within last 4 weeks prior to baseline subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease subjects hypersensitive to salicylates/aspirin subjects with moderate or 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

City

Bonheiden

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

16984503

Citation

D'Haens G, Hommes D, Engels L, Baert F, van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1087-97. doi: 10.1111/j.1365-2036.2006.03082.x.

Results Reference

result

Links:

URL

http://www.lialda.com/

Description

FDA-approved label, US only

URL

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

Description

FDA Recall information

Learn more about this trial

Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

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