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.

Condition	Intervention	Phase
Colitis, Ulcerative	Drug: mesalazine	Phase III

Further Study Details: 

Primary Outcomes: Endoscopic remission at 6 months
Secondary Outcomes: Time to endoscopic relapse; UC-DAI score, physician''''s global assessment; Safety and tolerability
Expected Total Enrollment:  410

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00151892

D. Anderson & Company      888-788-3982    DAC@telerep.com

District of Columbia
      Washington Gastroenterology, Washington,  District of Columbia,  United States; Recruiting
Florida
      Southern Clinical Research Consultants, Hollywood,  Florida,  United States; Recruiting
Illinois
      Midwest Clinical Research Center, Moline,  Illinois,  United States; Recruiting
Iowa
      Gastrointestinal Clinic of Quad Cities, Davenport,  Iowa,  United States; Recruiting
Louisiana
      Drug Research Services, Inc., Metairie,  Louisiana,  United States; Recruiting
New York
      New York Center for Clinical Research, Lake Success,  New York,  United States; Recruiting
North Carolina
      Piedmont Medical Research Associates, Inc., Winston Salem,  North Carolina,  United States; Recruiting
Belgium
      Imeldaziekenhais, Bonheiden,  Belgium; Recruiting
France
      CHU de Grenoble, Grenoble,  France; Recruiting
      Hospital Haut Leveque, Pessac,  France; Recruiting
Germany
      Deutsche Klinik fuer Diagnostik, Wiesbaden,  Germany; Recruiting
      Universitatsklinikum Freiburg, Freiburg,  Germany; Recruiting
      Universitatsklinikum Homburg/Saar, Homburg,  Germany; Recruiting
Hungary
      Fovarosi Onkormanyzat Peterfy Sandor utcai Korhaza - Gasztroenterologia, Budapest,  Hungary; Recruiting
      Heves Megyei Onkormanyzat, Eger,  Hungary; Recruiting
      Semmelweis Egyetem, Budapest,  Hungary; Recruiting
Russian Federation
      Scientific Center of Coloproctology, Moscow,  Russian Federation; Recruiting
      City Clinical Hospital #51, Moscow,  Russian Federation; Recruiting

Study ID Numbers:  SPD476-304
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151892
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13