UMIN ID: UMIN000001813
Registered date:30/03/2009
Ramdomized phaseII trial of concurrent antiemetics with oral rehydration therapy for children with vomiting in the result of acute gastroentiritis
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | acute gastroenteritis |
| Date of first enrollment | 2009/03/01 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | simple oral ondansetron prior to oral rehydration therapy (ORT) by WHO method simple domperidon suppository pior to ORT by WHO method |
Outcome(s)
| Primary Outcome | proportion of children having vomiting episodes during ORT |
|---|---|
| Secondary Outcome | -Proportion of children excervated on dehydration status -Number of vomiting episode -Volume of oral rehydration salt -Proportion of need for intravenous fluid / administration -Adverse events -(Revisit rates) -problems of ORT education at outpatients section |
Key inclusion & exclusion criteria
| Age minimum | 1years-old |
|---|---|
| Age maximum | 10years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | none |
Related Information
| Primary Sponsor | Metropolitan clinical research network for acute illness in children |
|---|---|
| Secondary Sponsor | J-CRSU |
| Source(s) of Monetary Support | Tokyo metropolitan government |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshihiko Morikawa |
| Address | 2-8-29 Musashidai, Fuchu, Tokyo, JapanMusashidai, Fuchu, Tokyo, Japan Japan |
| Telephone | 042-300-5111 |
| yoshihiko_morikawa@tmhp.jp | |
| Affiliation | Metropolitan clinical research network for acute illness in children coodinating office |
| scientific contact | |
| Name | Masaru Miura |
| Address | 2-8-29 Musashidai, Fuchu, Tokyo, Japan Musashidai, Fuchu, Tokyo, Japan Japan |
| Telephone | 042-300-5111 |
| masaru_miura@tmhp.jp | |
| Affiliation | Tokyo Metropolitan Children's Medical Center Cardiology, Clinical Research Support Center |