UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010688 |
|---|---|
| Receipt number | R000012494 |
| Scientific Title | Random Phase II Study of Effectiveness of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy in the Patients with Gynecologic Malignancy |
| Date of disclosure of the study information | 2013/07/15 |
| Last modified on | 2016/11/14 10:09:58 |
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Basic information
Public title
Random Phase II Study of Effectiveness of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy in the Patients with Gynecologic Malignancy
Acronym
Random Phase II Study of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy
Scientific Title
Random Phase II Study of Effectiveness of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy in the Patients with Gynecologic Malignancy
Scientific Title:Acronym
Random Phase II Study of Laftidine and Pregabalin for Paclitacel-Induced Peripheral Neuropathy
Region
| Japan |
Condition
Condition
Paclitaxel-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
To access efficacy and safety of laftidine and pregabalin, respectively, for paclitaxel-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
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Adverse event
Feasibility
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of lafutidine (oral)
Interventions/Control_2
Administration of pregabalin (oral)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with gynecological malignancies (cancer in the ovary, peritoneum, tube, cervix, or endometrium) who have paclitaxel-induced peripheral neuropathy
2.Patients scheduled to receive the same regimen as a present regimen during at least 10 weeks
3.Patients obtained informed consent in a documented form
Key exclusion criteria
1.ECOG performance status: 3 or 4
2.Patients with neuropathy due to apparently other causes such as diabetes
3.Patients who have received more than two previous chemotherapy regimen
4.Patients with moderate to severe renal dysfunction (serum creatinine >1.5mg/ml, or creatinine clearance <30ml/min)
5.Patients with severe congestive heart failure
6.Patients with angioedema
7.Patients who have been administered laftidine or pregabalin previously for peripheral neuropathy
8.Patients taking any antidepressants or any anticonvulsants
9.Patients for whom completion of this study is deemed inappropriate for any reason
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Obstetrics and Gynecology
Zip code
Address
2-1-10, Nishiogu, Arakawa-ku
TEL
03-3810-1111
naganoog@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Obstetrics and Gynecology
Zip code
Address
2-1-10, Nishiogu, Arakawa-ku
TEL
03-3810-1111
Homepage URL
naganoog@dnh.twmu.ac.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization
Non profit foundation
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
YES
Study ID_1
KCOG-G1304
Org. issuing International ID_1
Kansai Clinical Oncology Group
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 | 15 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012494
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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