Phase 3
N=829
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT00151892 ↗Enrolled (actual)
829
Serious AEs
1.1%
Results posted
Sep 2010
Primary outcome: Primary: Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months — 83.7; 81.5 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPD476 (Drug); Asacol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months |
83.7; 81.5 | — |
| SECONDARY Withdrawal Due to Relapse of UC |
12.8; 14.6 | — |
| SECONDARY Endoscopic Remission of UC With No or Mild Symptoms at 6 Months |
79.0; 75.6 | — |
| SECONDARY Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months |
0.061; 0.059 | — |
| SECONDARY Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score |
59.523; 59.664 | — |
Summary
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.
Eligibility Criteria
Inclusion Criteria
- previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
- female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception
Exclusion Criteria
- proctitis
- previous resective colonic surgery
- Crohn's disease
- hypersensitivity to salicylates
- moderate/severe renal impairment
Data sourced from ClinicalTrials.gov (NCT00151892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.