Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00545389
First received: October 16, 2007
Last updated: June 18, 2009
Last verified: November 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Development LLC:
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 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: Directorate general for the protection of Public health: Medicines 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 October 17, 2012
