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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00545389

Enrollment

Registered

2007-10-17

Start date

2003-02-10

Completion date

2004-10-20

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

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).

Interventions

DRUGSPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
% of subjects in remission (UC-DAI score)	Week 8

Secondary

Measure	Time frame
Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology	8 weeks
Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA	8 weeks
Safety and tolerability	8 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026