UMIN ID: UMIN000053935
Registered date:01/05/2024
Exploring factors contributing to the efficacy of adhesion molecule inhibitors for ulcerative colitis: a multi-center study in Japan
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Ulcerative colitis |
| Date of first enrollment | 2024/05/01 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | exploring the factors related to the endoscopic improvement at 6 months after starting the remission induction therapy. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Subjects who don't provide written consent by themselves or their guardians. (2)Subjects who had total or partial colectomy. (3)Subjects diagnosed with proctitis or an undetermined disease type. (4)Subjects suspected concomitant colitis due to other reasons. (5)Subjects with an emergent, critical condition of ulcerative colitis (e.g., fulminant UC, toxic megacolon, uncontrollable bleeding). |
Related Information
| Primary Sponsor | Kyorin University School of Medicine |
|---|---|
| Secondary Sponsor | Sapporo Medical University, Dept. Gastroenterology and Hepatology Toho University Sakura Medical Center, Dept. Gastroenterology and Hepatology Kitasato University Kitasato Institute Hospital, Dept. Gastroenterology and Hepatology |
| Source(s) of Monetary Support | Self-funding EA Pharma Co., Ltd. Kissei Pharmaceutical Co., Ltd.,EA Pharma Co., Ltd. Kissei Pharmaceutical Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Jun Miyoshi |
| Address | 6-20-2 Shinkawa, Mitaka-shi, Tokyo Japan 181-8611 |
| Telephone | 0422-47-5511 |
| jmiyoshi@ks.kyorin-u.ac.jp | |
| Affiliation | Kyorin University School of Medicine Department of Gastroenterology and Hepatology |
| scientific contact | |
| Name | Tadakazu Hisamatsu |
| Address | 6-20-2 Shinkawa, Mitaka-shi, Tokyo Japan |
| Telephone | 0422-47-5511 |
| thisamatsu@ks.kyorin-u.ac.jp | |
| Affiliation | Kyorin University School of Medicine Department of Gastroenterology and Hepatology |