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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011332
Receipt No. 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

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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
Obsterics 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
Last 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
Email

Public contact
1st 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
Email sugita.kenji@nihon-u.ac.jp

Sponsor
Institute Nihon University Itabashi Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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