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Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00548574
First received: October 23, 2007
Last updated: May 5, 2009
Last verified: November 2007
History of Changes
  Purpose

The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo


Condition Intervention Phase
Ulcerative Colitis
 Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
Drug: Mesalazine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multi-Centre, Double-Blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With 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 (UC-DAI score <=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 from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA [ Time Frame: 8 weeks ]
  • Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score [ Time Frame: 8 weeks ]
  • Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score [ Time Frame: 8 weeks ]

Enrollment: 343
Study Start Date: December 2003
Study Completion Date: July 2005
Intervention Details:
    Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
    Other Name: LIALDA
    Drug: Mesalazine
    Other Name: ASACOL
  Eligibility

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

Inclusion Criteria:

  • newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of => 1 and a PGA <=2) with compatible histology
  • females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception

Exclusion Criteria:

  • subjects with relapsing UC who were in relapse for > 6 weeks prior to baseline
  • subjects who relapsed on maintenace therapy with doses of mesalazine => 2g/day
  • subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of > 2g/day
  • subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
  • subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
  • subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548574

Locations
Belgium
Imelda General Hospital Dept of Gastroenterology
Bonheiden, Belgium
Sponsors and Collaborators
Shire Development LLC
Investigators
Principal Investigator: Professor Michael Kamm St Marks Hospital, London, UK
  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: NCT00548574     History of Changes
Other Study ID Numbers: SPD476-302
Study First Received: October 23, 2007
Last Updated: May 5, 2009
Health Authority: France: Institutional Ethical Committee

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