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
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: 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 July 28, 2014