UMIN ID: UMIN000001375
Registered date:14/09/2008
Clinical trial on the incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin: a randamized control study using transnasal endoscopy in healthy volunteers
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | upper gastrointestinal mucosal injury |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | three kinds of placeboes for 7 days Enteric-coated aspirin 100 mg/day + two kinds of placeboes for 7 days Enteric-coated aspirin 100 mg/day + rebamipide 300mg/day + placebo for 7 days Enteric-coated aspirin 100 mg/day + omeprazole 20mg/day + placebo for 7 days |
Outcome(s)
| Primary Outcome | The number of transnasal endoscopic findings (red spots, petechiae, erosion, ulcer) |
|---|---|
| Secondary Outcome | Symptom assessment (using GSRS) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | a. hemorrhage tendency b. hypersensitivity for element of aspirin c. previous history of aspirin induced asthma d. previous history of peptic ulcer e. severe blood disease f. severe complication (malignant tumor, liver cirrhosis, renal failure, cardiac failure, etc) g. pregnant woman,or possibility of pregnancy h. smoker i. Inadequate to entry judged by investigators |
Related Information
| Primary Sponsor | Endoscopy Center, Tokyo Medical University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Endoscopy Center, Tokyo Medical University Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takashi Kawai |
| Address | 6-7-1, Nishishinjuku,Shinjuku-ku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Tokyo Medical University Hospital Endoscopy Center |
| scientific contact | |
| Name | Takashi Kawai |
| Address | 6-7-1, Nishishinjuku,Shinjuku-ku, Tokyo, Japan Japan |
| Telephone | 03-3342-6111 |
| Affiliation | Tokyo Medical University Hospital Endoscopy Center |