Ulcerative Colitis
Conditions
Interventions
A 24-week administration of 4.8g/day of Asacol
A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with ulcerative clolitis 2) Patients whose UCDAI score between 3 and 6 points (bloody stool score is more than 1 point) 3) Patients who are taking 3.6g of Asacol or 4.0g of Pentasa daily. 4) Patients who are over 15 and under 70 years of age.
Exclusion criteria
Exclusion criteria: 1) Patients who took mesalazine enema or salazopyrine suppository in 2 weeks before the day of the registration for this study 2) Patients who took steroid fomula in 1 month before that day 3) Patients who started to take immunomodulators or to escalate the dose of the medicine before that day. In addition, the patients who took the drug more than 90 days without dose-escalation are not excluded. 4) Patients who started to take anti-TNFa therapy before that day. In addition, the patients who took the therapy more than 90 days are not excluded. 5) Patients who took cytapheresis in 2 weeks before that day. 6) Patients who took antidiarrheal or antispasmodic drugs after screening examination. 7) Patients who used nicotine patch, received antibiotics and any product containing omega-3 fatty acids within the last 7 days. 8) Patients who is participated other clinical trials. 9) Patients who have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the deylayed-release mesalazine tablets. 10) Patients who have a history of serious adverse event to mesalazine. 11) Patients who have renal or hepatic diseases. 12) Patients whose stool examination positive for Clostridium difficile, bacterial pathogens, or ova and parasites. 13) Patients who have a history of alcohol abuse. 14) Patients who were diagnosed malignant neoplasms. 15) Patients who were pregnant and/or lactating women. 16) Patients who are having an effect of the adverse event by an investigational new drug (or a drug in Phase IV) in other clinical trial previously. 17) Patients who were considered unsuitable for this study by participant doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at week 24 by UCDAI score | — |
Countries
Japan
Outcome results
None listed