Unique ID issued by UMIN | UMIN000013725 |
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Receipt number | R000016024 |
Scientific Title | Double Phase Clinical Trial to Investigate Prevalence of Neuropathic Pain in Gynecologic Cancer Patients and Efficacy and Safety of Opioids on Pain Management among the Same Population |
Date of disclosure of the study information | 2014/04/15 |
Last modified on | 2020/04/19 09:32:19 |
Double Phase Clinical Trial to Investigate Prevalence of Neuropathic Pain in Gynecologic Cancer Patients and Efficacy and Safety of Opioids on Pain Management among the Same Population
INGyCO study
Double Phase Clinical Trial to Investigate Prevalence of Neuropathic Pain in Gynecologic Cancer Patients and Efficacy and Safety of Opioids on Pain Management among the Same Population
INGyCO study
Japan |
Gynecologic malignancies
Obstetrics and Gynecology |
Malignancy
NO
to examine efficacy and safety of controlled-release opioids in neuropathic pain among gynecologic cancer patients.
Safety,Efficacy
1.Patient demographics
2.Pain related
3.QOL related
4.Adverse events
5.Laboratory data
6.Imaging
Observational
20 | years-old | <= |
Not applicable |
Female
1. Patients over 20 ages at study entry
2. Patients suffered from neuropathic pain rated over 4 by NRS
3. Patients not administered opioids within 2 weeks before study entry
4. Patients able to communicate and assess his/her own symptoms
5. Patients assessed ECOG-PS as 0-3
6. Patients expecting over 2 months estimate survival after study opening
7. Patients with neuropathic pain due to cancer (nerve compression, invasion to plexus), or mixed pain with cancer treatment related pain(surgery, chemotherapy, radiotherapy)
8. Patients agreed with the written informed consent
1. Patients hypersensitive to opium alkaloids
2. Patients with serious depressed respiration or serious chronic obstructive lung disease (refer to contraindication)
3. Patients received surgery, chemotherapy or palliative radiotherapy within 2 weeks affected pain assessment, or scheduled these therapies during study period
4. Patients with severely impaired hepatic or renal function
5. Patients pregnant or possibly pregnant
6. Patients with cancer treatment related pain solely
7. Patients judged unsuitable for study subject by responsible physicians due to other clinical reasons
60
1st name | Akiko |
Middle name | |
Last name | Tozawa |
St. Marianna University School of Medicine
Obstatrics and Gynecology
216-8511
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
044-977-8111
a2ono@marianna-u.ac.jp
1st name | Akiko |
Middle name | |
Last name | Tozawa |
St. Marianna University School of Medicine
Obstatrics and Gynecology
216-8511
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
0449778111
a2ono@marianna-u.ac.jp
St. Marianna University School of Medicine
Japanese Society of Palliative Medicine (JSGPM)
Other
Division of Graduate Student Affairs and Research Promotion
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
NO
2014 | Year | 04 | Month | 15 | Day |
Unpublished
Completed
2014 | Year | 04 | Month | 04 | Day |
2014 | Year | 04 | Month | 21 | Day |
2014 | Year | 04 | Month | 21 | Day |
2019 | Year | 03 | Month | 31 | Day |
Efficacy and Safety of Opioids in Neuropathic Pain in Gynecologic Cancer Patients for 4 weeks
2014 | Year | 04 | Month | 15 | Day |
2020 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016024
Research Plan | |
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Registered date | File name |
2016/10/17 | 前向きコホート研究実施計画書20160722.doc |
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Registered date | File name |
Research case data | |
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Registered date | File name |