UMIN ID: UMIN000001507
Registered date:15/11/2008
Randomized controlled trial of the effect of irsogladine maleate on the mucosal injury of small intestine in regular users of loxoprofen sodium
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | mucosal injury of small intestine due to NSAID |
| Date of first enrollment | 2008/11/01 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | irsogladine maleate no treatment control |
Outcome(s)
| Primary Outcome | grade, number, and improvement of small intestinal lesions evaluated by capsule endoscopy |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) patients taking misoprostol 2) patients taking other NSAIDs, steroid, anti-platelet agents except aspirin, anti-coagulants, or anti-cancer drugs 3) patients with contraindication to capsule endoscopy 4) patients with active bleeding lesions 5) severely ill patients |
Related Information
| Primary Sponsor | Department of Gastroenterology, The University of Tokyo Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Gastroenterology, The University of Tokyo Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 03-3815-5411(33070) |
| Affiliation | The University of Tokyo Hospital Department of Gastroenterology |
| scientific contact | |
| Name | Yamaji Yutaka |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | |
| Affiliation | The University of Tokyo Hospital Department of Gastroenterology |