Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00503243
• Collaborator: (none)
• Enrollment: 280
• Location: 1
• Actual Duration (Months): 15.6
• Patients Per Site Per Month: 17.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Delayed and extended release mesalazine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
• Actual Study Start Date: Sep 30, 2003
• Actual Primary Completion Date: Jan 17, 2005
• Actual Study Completion Date: Jan 17, 2005

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score [8 weeks]

2. Change in the UC-DAI score [8 weeks]

3. Change in symptoms (rectal bleeding and stool frequency) [2, 4 and 8 weeks]

4. Change in sigmoidoscopic (mucosal) appearance [8 weeks]

5. Time to withdrawal from the start of study medication [Throughout the study period of 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00503243
• Other Study ID Numbers: SPD476-301; 2004-000733-12
• First Posted: Jul 18, 2007
• Last Update Posted: Jun 11, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Mesalamine

Study Results

No Results Posted as of Jun 11, 2021