JRCT ID: jRCT2080222089
Registered date:24/05/2013
Phase III Study of Z-206
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Ulcerative Colitis |
| Date of first enrollment | 24/05/2013 |
| Target sample size | 600 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | investigational material(s) Generic name etc : Z-206 INN of investigational material : Mesalazine Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Mesalazine at the dose 2.4g/day is administered once a day or three times a day. |
Outcome(s)
| Primary Outcome | The proportion of patients without relapse |
|---|---|
| Secondary Outcome | The time to relapse |
Key inclusion & exclusion criteria
| Age minimum | >= 16age old |
|---|---|
| Age maximum | <= 64age old |
| Gender | Both |
| Include criteria | -Those who are with ulcerative colitis in remission state etc. |
| Exclude criteria | -Those who have a history of drug hypersensitivity to mesalazine or salicylic acid series etc. |
Related Information
| Primary Sponsor | Zeria Pharmaceutical Co., Ltd. |
|---|---|
| Secondary Sponsor | Kyowa Hakko Kirin Co., Ltd. |
| Source(s) of Monetary Support | ZERIA Pharmaceutical Co., Ltd |
| Secondary ID(s) | JapicCTI-132135 |
Contact
| Public contact | |
| Name | |
| Address | 03-5644-7053 |
| Telephone | |
| Affiliation | ZERIA Pharmaceutical Co., Ltd |
| Scientific contact | |
| Name | |
| Address | 03-3661-0276 |
| Telephone | |
| Affiliation | ZERIA Pharmaceutical Co., Ltd |