Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00545389
First received: October 16, 2007
Last updated: June 18, 2009
Last verified: November 2007
  Purpose

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).


Condition Intervention Phase
Colitis, Ulcerative
Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Multi-Centre, Double-Blind, Parallel-Group, Dose-Ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • % of subjects in remission (UC-DAI score) [ Time Frame: Week 8 ]

Secondary Outcome Measures:
  • Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology [ Time Frame: 8 weeks ]
  • Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA [ Time Frame: 8 weeks ]
  • Safety and tolerability [ Time Frame: 8 weeks ]

Enrollment: 38
Study Start Date: February 2003
Study Completion Date: October 2004
Intervention Details:
    Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
    Other Name: LIALDA
  Eligibility

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

Inclusion Criteria:

  • male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
  • general medical assessment satisfactory and no clinically significant and relevant abnormalities

Exclusion Criteria:

  • severe ulcerative colitis
  • subject in relapse for > 6 weeks
  • use of systemic or rectal steroids within last 4 weeks prior to baseline
  • subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
  • subjects hypersensitive to salicylates/aspirin
  • subjects with moderate or severe renal impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545389

Locations
Belgium
Imelda General Hospital
Bonheiden, Belgium
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Prof Dr Geert D'Haens Imelda General Hospital, Belgium
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00545389     History of Changes
Other Study ID Numbers: SPD476-202
Study First Received: October 16, 2007
Last Updated: June 18, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products

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 April 22, 2014