Unique ID issued by UMIN | UMIN000024466 |
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Receipt number | R000028161 |
Scientific Title | Acotiamide Oral Therapy in Acute Phase for Postgastrectomy Syndrome |
Date of disclosure of the study information | 2016/10/25 |
Last modified on | 2017/02/06 20:36:12 |
Acotiamide Oral Therapy in Acute Phase for Postgastrectomy Syndrome
Acotiamide Oral Therapy in Acute Phase for Postgastrectomy Syndrome
Acotiamide Oral Therapy in Acute Phase for Postgastrectomy Syndrome
Acotiamide Oral Therapy in Acute Phase for Postgastrectomy Syndrome
Japan |
Postgastrectomy Syndrome
Gastroenterology | Surgery in general | Gastrointestinal surgery |
Others
NO
The aim of this study is to evaluate the effectiveness of acotiamide for the functional dyspepsia of postgastrectomy.
Safety,Efficacy
Evaluating symptom diaries utilizing Roma III standards categories (On weeks 1,2,3,4,8)
Achieving over 70% of the pre-operational food intake (On weeks 2,4,8). Intra-abdominal fat evaluation and evaluation for atrophy rate of psoas major by CT-scan on the 8 week post surgery. Nutritional index evaluation (prealbumin,retinol-binding protein,albumin,GLP-1), SF-NDI scale,F-scale (On weeks 0,4,8).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Orally intake acotiamide(100mg) three times a day for 8 weeks starting from 4-7 days post operation.
20 | years-old | <= |
85 | years-old | > |
Male and Female
1.Age: Age over 20 years old and below 85 years old at the time of consent
2.Sex: Male and Female
3.In-patient/Out-patient: Either
4.Patients who have undergone gastrectomy and gasric-reconstruction and have started food intake within 3 to 7 days post operation.
5.Patients who consent and sign with complete understanding of the study after adequate explanation as to the particulars of the study, or patients whose guardian consents to their participation in the study.
1.Cases where gastrectomy was not radical operation (Peritoneal dissemination etc.)
2.Cases with enterostomy
3.Cases with total gastrectomy
4.Patients with medication sensitivity
5.Patients during pregnancy and lactation.
6.Patients who test responsibility (sharing) doctor has determined to be inappropriate as a subject.
35
1st name | |
Middle name | |
Last name | Eguchi Susumu |
Nagasaki University Graduate School of Biomedical Sciences
Surgery
Sakamoto 1-7-1, Nagasaki city
0958197316
sueguchi@nagasaki-u.ac.jp
1st name | |
Middle name | |
Last name | Shinichiro Kobayashi |
Nagasaki University Graduate School of Biomedical Sciences
Surgery
Sakamoto 1-7-1, Nagasaki city
0958197316
shinichirokobayashi@nagasaki-u.ac.jp
Nagasaki University
none
Self funding
NO
2016 | Year | 10 | Month | 25 | Day |
Unpublished
Preinitiation
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 10 | Month | 20 | Day |
2016 | Year | 10 | Month | 18 | Day |
2017 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028161
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