UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011332 |
|---|---|
| Receipt number | R000013277 |
| Scientific Title | Comparing investigation of the curative effect by Goshajinkigan and Pregabalin for -Induced Peripheral Neuropathy |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2013/08/06 20:23:48 |
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Basic information
Public title
Comparing investigation of the curative effect by Goshajinkigan and Pregabalin for -Induced Peripheral Neuropathy
Acronym
The efficacy of Goshajinkigan and Pregabalin for Paclitacel-Induced Peripheral Neuropathy
Scientific Title
Comparing investigation of the curative effect by Goshajinkigan and Pregabalin for -Induced Peripheral Neuropathy
Scientific Title:Acronym
The efficacy of Goshajinkigan and Pregabalin for Paclitacel-Induced Peripheral Neuropathy
Region
| Japan |
Condition
Condition
Paclitacel -induced peripheral neuropathy in the patients with gynecological malignancies
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of Goshajinkigan and Pregabalin for Paclitacel -induced peripheral neuropathy in the patients with gynecological malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The level of improvement of peripheral neuropathy is evaluated by Numeric Rating Scale (NRS) after 8 weeks of chemotherapy starts.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pregabalin is administered orally at the dose of 25 mg at bedtime. And it is increased sequentially.
Interventions/Control_2
Goshajinkigan is administered orally at the dose of 2.5g three times daily.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Patients with gynecological malignancies who have paclitaxel-induced peripheral neuropathy
2)Patients scheduled to receive the chemotherapy by paclitaxel at least 3course
3)The patient by whom the survival for 4 months or more is expected
4)Patients obtained informed consent in a documented form
Key exclusion criteria
1) Patients with severe complications (such as heart failure, renal failure, liver failure, blood disease)
2)Patients with neuropathy due to apparently other causes such as diabetes or cingulum
3)Patients with history of allergy in Pregabalin or Goshajinkigan
4)Patient with the neurological symptoms by brain metastasis or bone metastasis
5)Patients who have been administered Pregabalin or Goshajinkigan previously for peripheral neuropathy
6)Patients for whom completion of this study is deemed inappropriate for any reason
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sugita |
Organization
Nihon University Itabashi Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
30-1, Oyagichi-kamimachi, Itabashi-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Sugita |
Organization
Nihon University Itabashi Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
TEL
03-3972-8111
Homepage URL
sugita.kenji@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2013 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013277
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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