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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:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00503243
First received: July 16, 2007
Last updated: June 26, 2009
Last verified: November 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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 Development LLC
  More Information

Additional Information:
FDA Recall information  This link exits the ClinicalTrials.gov site
FDA Medical Product Safety Alerts  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00503243     History of Changes
Other Study ID Numbers: SPD476-301
Study First Received: July 16, 2007
Last Updated: June 26, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013