Crohn'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: > Disease located in small intestine, small/large intestine, or large intestine. > 180 <= CDAI < 450 > For steroid administration, dosage is 10 mg/day or less as Predonine
Exclusion criteria
Exclusion criteria: > Using over 3 g/day mesalazine and/or topical formulation of mesalazine within 4 weeks. > Using over 10 mg steroid as Predonine and/or a topical formulation of steroid, an immune modulator, or a biological drug within 4 weeks. > Being steroid-dependent (relapse within 3 months without steroid). > Pregnant or suspected of being pregnant. > Having a history of a drug reaction(s) to Pentasa or Salicylic acid, etc. > Having a dysfunction of the liver or kidney, and judged to be unsuitable for taking mesalazine. > Confirming symptoms of stenosis such as stomachache or increased gurgle, or stenosis of 1/2 lumen by small bowel series. > Being under the influence of a previous adverse reaction(s) from other clinical trials. > Being under treatment for malignancy > Short bowel syndrome by intestinal resection. > Having had cytapheresis within 4 weeks. > Judged to be unsuitable for enrollment for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crohn's disease Activity Index | — |
Secondary
| Measure | Time frame |
|---|---|
| > Decrease in dosage of steroid > Improvement of endoscopic score | — |
Countries
Japan
Contacts
Theravalues Corporation Science group