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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:
ClinicalTrials.gov Identifier:
NCT00548574
First Posted: October 24, 2007
Last Update Posted: March 5, 2015
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 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Shire:

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

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 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
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): NCT00548574


Locations
Belgium
Imelda General Hospital Dept of Gastroenterology
Bonheiden, Belgium
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Professor Michael Kamm St Marks Hospital, London, UK
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00548574     History of Changes
Other Study ID Numbers: SPD476-302
First Submitted: October 23, 2007
First Posted: October 24, 2007
Last Update Posted: March 5, 2015
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