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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503243
First Posted: July 18, 2007
Last Update Posted: June 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shire:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503243


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Shire
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00503243     History of Changes
Other Study ID Numbers: SPD476-301
2004-000733-12 ( EudraCT Number )
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: June 9, 2014
Last Verified: November 2007

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents