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

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.
 
ClinicalTrials.gov Identifier: NCT00545389
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : June 19, 2009
Sponsor:
Information provided by:
Shire

Brief Summary:
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 or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2003
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
    Other Name: LIALDA


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

Secondary Outcome Measures :
  1. 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 ]
  2. Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA [ Time Frame: 8 weeks ]
  3. Safety and tolerability [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00545389


Locations
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Belgium
Imelda General Hospital
Bonheiden, Belgium
Sponsors and Collaborators
Shire
Investigators
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Principal Investigator: Prof Dr Geert D'Haens Imelda General Hospital, Belgium
Additional Information:
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00545389    
Other Study ID Numbers: SPD476-202
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: November 2007
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
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