Unique ID issued by UMIN | UMIN000031381 |
---|---|
Receipt number | R000035834 |
Scientific Title | PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2019/04/03 09:15:17 |
PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study
Phase-R OIC study
PHarmacological Audit study of Safety and Effectiveness in Real world: Naldemedine for Opioid-Induced Constipation study
Phase-R OIC study
Japan |
opioid-induced constipation
Gastroenterology | Hematology and clinical oncology |
Malignancy
NO
To examine the safety and effectiveness of naldemedine for patients with cancer and opioid-induced constipation
Safety,Efficacy
Spontaneous bowel movements within 24 hours after first naldemedine administration
Number of spontaneous bowel movements during 1 week after first naldemedine administration
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) adult patients with cancer receiving care from palliative care teams or in palliative care units
2) scheduled naldemedine administration for opioid-induced constipation
3) planned to receive sustained doses of opioid and laxatives
1) patients with suspected malignant bowel obstruction, or previous history of malignant bowel obstruction and high recurrence risk
2) prior naldemedine administration
200
1st name | |
Middle name | |
Last name | Masaki Shimizu |
National Cancer Center
Department of Palliative Medicine
5-1-1 Tsukiji Chuo-ku, Tokyo, Japan
03-3542-2511
masshimi@ncc.go.jp
1st name | |
Middle name | |
Last name | Keisuke Ariyoshi |
JORTC Data Center
Department of Data Management
2-54-6-302 Nishinippori, Arakawa-ku, Tokyo, Japan
03-5604-9850
keisuke.ariyoshi@jortc.jp
National Cancer Center
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 28 | Day |
2018 | Year | 04 | Month | 17 | Day |
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
Safety and effectiveness of naldemedine for opioid-induce constipation will be evaluated at Day 7.
2018 | Year | 02 | Month | 20 | Day |
2019 | Year | 04 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035834
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |