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

This study has been completed.

First Received: July 16, 2007 Last Updated: November 13, 2008 History of Changes

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00503243

Purpose

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	Intervention	Phase
Colitis, Ulcerative	Drug: Delayed and extended release mesalazine	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

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 [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score [ Time Frame: 8 weeks ]
Change in the UC-DAI score [ Time Frame: 8 weeks ]
Change in symptoms (rectal bleeding and stool frequency) [ Time Frame: 2, 4 and 8 weeks ]
Change in sigmoidoscopic (mucosal) appearance [ Time Frame: 8 weeks ]
Time to withdrawal

Enrollment:	280
Study Start Date:	September 2003
Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503243

Locations

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Shire Pharmaceutical Development

More Information

Additional Information:

FDA-approved label, US only This link exits the ClinicalTrials.gov site

FDA Recall information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

Synopsis of study results This link exits the ClinicalTrials.gov site

Publications:

Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, Butler T, Lees K, Joseph RE, Sandborn WJ. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007 Jan;5(1):95-102.

Study ID Numbers:	SPD476-301
Study First Received:	July 16, 2007
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00503243 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Mesalamine
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases

Digestive System Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Mesalamine
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases

Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents
Colitis

ClinicalTrials.gov processed this record on May 07, 2009