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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545389
• Other study ID #: SPD476-202
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2003
• Est. completion date: October 20, 2004

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 20, 2004
• Est. primary completion date: October 20, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Belgium	Imelda General Hospital	Bonheiden

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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 T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of subjects in remission (UC-DAI score)		Week 8
Secondary	Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology		8 weeks
Secondary	Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA		8 weeks
Secondary	Safety and tolerability		8 weeks

External Links

•   FDA Recall information
•   FDA-approved label, US only