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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007974
Receipt No. R000009388
Scientific Title Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Date of disclosure of the study information 2012/05/17
Last modified on 2018/11/21

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Basic information
Public title Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Acronym Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Scientific Title Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Scientific Title:Acronym Treatment effect of pregabalin and etodolac in patients with paclitaxel-induced peripheral neuropathy -a verification study-
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the treatment effect of pregabalin and etodolac in patients with chemotherapy-induced peripheral neuropathy (CIPN).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Pain severity at 8 weeks after baseline (VAS, a self-administered questionnaire) (comparison with baseline)
Key secondary outcomes - VAS at every 4 weeks (except at 8 weeks)
- Severity of CIPN at every 4 weeks after baseline (PNQ) (comparison with baseline)
- CTCAE v4.0 at every 4 weeks after baseline (comparison with baseline)
- SF-36 at every 4 weeks after baseline (comparison with baseline)
- Questionnaire of pain due to numbness at every 4 weeks after baseline (comparison with baseline)
- Total dose, duration, and number of doses of paclitaxel
- Total dose of pregabalin, age, height, body weight, duration of the disease, laboratory values, disease stage, and concomitant medications
- Total dose of etodolac, age, height, body weight, duration of the disease, laboratory values, disease stage, and concomitant medications

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 NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pregabalin group:
Dose start from 75mg, before bed. Dose could be increased to 150 mg, BID, and 2 weeks later, the dose may be increased to 300 mg, BID.
Interventions/Control_2 Etodolac group:
2 tablets, BID. Dose may be increased up to 800 mg depending on the patient' s symptoms.
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) Female patients aged 20 years or older (regardless of hospitalization status)
2) Breast cancer patients with Grade D or E in PNQ
The following items are rated on a 3-point scale (0: none, 1: somewhat applicable, 2: very applicable), and when >=2 items are rated 2, the neuropathy is regarded as Grade D.
Then the study treatment would proceed.
(a) Unable to open a plastic bottle
(b) Unable to button your clothes
(c) Cannot write
(d) Drop things
(e) Unable to put on shoes
(f) Stumble
3) Patients without peripheral neuropathy (such as numbness) or any underlying disease causing peripheral neuropathy before the treatment
4) Patients who are able to answer the questionnaires written in Japanese without assistance
5) Patients who are going to receive >=2 cycles of paclitaxel chemotherapy
6) Patients expected to survive for at least 4 months
7) Patients who agreed to participate in the study and signed informed consent form
Key exclusion criteria 1) Patients with a current or past history of gastrointestinal hemorrhage or peptic ulcer
2) Patients with a current or past history of serious complications such as cardiac, renal, hepatic, and hematological disorders
3) Patients with neuropathic pain due to diabetes mellitus or herpes zoster
4) Patients with a history of hypersensitivity to pregabalin or etodolac
5) Patients with neurological symptoms due to brain and/or bone metastases
6) Patients who used pregabalin or etodolac for treating pain possibly associated with paclitaxel
7) Other patients considered to be ineligible to participate in the study by the investigator
Target sample size 144

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoshi Hosokawa
Organization University Hospital, Kyoto Prefectural University of Medicine
Division name Departments of Pain Treatment and Palliative Care Unit
Zip code
Address 465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-8566
TEL 075-251-5177
Email hosobon@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Midori Morita
Organization Kyoto Prefectural University of Medicine
Division name Department of Endocrine and Breast Surgery
Zip code
Address 465 kajii-cho, Kawaramachi St. Hirokoji, kamikyo-ku, Kyoto, 602-0841
TEL 0752515534
Homepage URL
Email midori@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 京都府立医科大学附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 17 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
2011 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 17 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009388

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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