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
ClinicalTrials.gov Identifier:
NCT00503243
First received: July 16, 2007
Last updated: June 6, 2014
Last verified: November 2007
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00503243     History of Changes
Other Study ID Numbers: SPD476-301, 2004-000733-12
Study First Received: July 16, 2007
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014