UMIN ID: UMIN000000958
Registered date:27/12/2007
Randomized Contorolled Trial of efficacy of mosapride plus omeprazole versus omeprazole alone in therapy of gastroesophageal reflux disease
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | gastroesophageal reflux disease |
| Date of first enrollment | 2007/10/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | omeprazole 10mg qd after breakfast for 4 weeks omeprazole 10mg qd after breakfast plus mosapride 5mg tid for 4 weeks |
Outcome(s)
| Primary Outcome | The primary efficacy endpoint is improvement in the FSSG(Frequency Scale for the Symptoms of GERD).The FSSG was performed before the study.After 4 weeks of therapy with either regimen, FSSG was performed again.The levels of the improvement of the GERD symptom are compared in omeprazole and omeprazole plus mosapride . |
|---|---|
| Secondary Outcome | 1.GSRS score after 4 weeks 2.FSSG score stratified by nonerosive GERD and erosive GERD |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 99years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The patient who collides with either the following assumes that it doesn't put it in to the examination 1)Patient with gastric or duodenal ulcer 2)Patient with malignant neoplasm, diabetes or thyroid disease 3)Patient who has severe liver disease.(AST(GOT) or ALT(GPT) is 100 U or more ) 4)Patient who has severe renal dysfunction(BUN 25mg/dL or more or serum creatinine 2.0 mg/dL or more) 5)Patient who has the pasts of digestive tract operations other than appendectomy 6)Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks 7)Alcohol or drug abuse 8)Pregnant females and lactating women 9)Patient whom examination doctor judged improper as testee |
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 | Yutaka Yamaji |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | |
| Affiliation | The University of Tokyo Hospital Department of Gastroenterology |