UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011393
Receipt number R000013337
Scientific Title Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin.
Date of disclosure of the study information 2013/08/07
Last modified on 2019/02/08 14:14:34

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Basic information

Public title

Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin.

Acronym

Pre-XOX study

Scientific Title

Feasibility study of lidocaine for peripheral venous pain induced by oxaliplatin.

Scientific Title:Acronym

Pre-XOX study

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aim to explore the safety of lidocaine intravenous infusion for the purpose of relieving the peripheral venous pain induced by oxaliplatin, and to determine the recommended dose(RD) in the phase II study by the frequency of dose-limiting toxicity(DLT).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

To evaluate feasibility and to determine the recommended dose

Key secondary outcomes

The degree of venous pain
Blood concentration of lidocaine : pharmacokinetics


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lidocaine will be administrated continuous IV in parallel with oxaliplatin.

Interventions/Control_2


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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Histologically proven adenocarcinoma of colorectal cancer.
2. Be to administered of more than 100 mg per sqm of oxaliplatin via peripheral vein.
3. Able to be cutdown in 22G indwelling needle in the elbow or forearm
4. Age: 20 years to 75 years
5. PS(ECOG) 0-1
6. Adequate main organ functions
7. Written informed consent by the participant

Key exclusion criteria

1. History of treatment with oxaliplatin
2. Pain or cutaneous symptoms in the arm
3. Unable to be self-assessment of pain
4. Contraindication for the each medicine
5. Serious abnormalty in ECG requiring treatment
6. Administration of anti-arrhythmic.
7. Administration of adjuvant analgesics in neuropathic pain
8. Sever complications
9. Pregnancy, or lactation
10. History of drug hypersenstitivity.
11. Others

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miwako Uemori

Organization

Saito Yukoukai Hospital

Division name

Department of pharmacy

Zip code


Address

7-2-18, Saito-Asagi, Ibaraki City, Osaka, Japan

TEL

+81-72-641-6898

Email

dsakai@cfs.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miwako Uemori

Organization

Saito Yukoukai Hospital

Division name

Department of pharmacy

Zip code


Address

7-2-18, Saito-Asagi, Ibaraki City, Osaka, Japan

TEL

+81-72-641-6898

Homepage URL


Email

dsakai@cfs.med.osaka-u.ac.jp


Sponsor or person

Institute

Saito Yukokai Hospital

Institute

Department

Personal name



Funding Source

Organization

Saito Yukokai Hospital

Organization

Division

Category of Funding Organization

Self funding

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 08 Month 07 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

Completed

Date of protocol fixation

2013 Year 07 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 13 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 08 Month 06 Day

Last modified on

2019 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name