UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024568
Receipt number R000028276
Scientific Title Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients
Date of disclosure of the study information 2016/10/26
Last modified on 2020/11/16 11:42:38

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Basic information

Public title

Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients

Acronym

Pregabalin PK-PD in Japanese pain patients

Scientific Title

Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients

Scientific Title:Acronym

Pregabalin PK-PD in Japanese pain patients

Region

Japan


Condition

Condition

Pain

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Psychosomatic Internal Medicine Geriatrics
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Oto-rhino-laryngology Orthopedics
Urology Radiology Anesthesiology
Oral surgery Neurosurgery Cardiovascular surgery
Plastic surgery Operative medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The aim of this study is to explore a factor affecting the interindividual variability in clinical responses to pregabalin.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Plasma concentrations of pregabalin at 96 hours or later after initiation of oral pregabalin therapy.

Key secondary outcomes

1.Analgesic effect (numerical rating scale)
2.Adverse reaction (dizziness, somnolence, dry mouth, edema, weight gain)
3.Renal function (estimated glomerular filtration rate, creatinine clearance)
4.GPS(glasgow prognostic score)
5.Classification of cancer cachexia (pre-cachexia, cachexia syndrome, refractory cachexia)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients receiving pregabalin for the treatment of pain
2.Patients who can give written informed consent

Key exclusion criteria

1.Patients discontinued the treatment of pregabalin
2.Patients having severe kidney dysfunction or liver dysfunction
3.Patients assessed as inappropriate for the study enrollment by the attending physician

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Junichi
Middle name
Last name Kawakami

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital pharmacy

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka

TEL

053-435-2762

Email

pharmacyham-adm@umin.ac.jp


Public contact

Name of contact person

1st name Takafumi
Middle name
Last name Naito

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital pharmacy

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka

TEL

053-435-2623

Homepage URL


Email

pharmacyham-adm@umin.ac.jp


Sponsor or person

Institute

Department of Hospital pharmacy, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Hospital pharmacy, Hamamatsu University School of Medicine

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

Ethics Committee of Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka

Tel

053-435-2111

Email

rinri@hama-med.ac.jp


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

2016 Year 10 Month 26 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

2015 Year 03 Month 12 Day

Date of IRB

2015 Year 03 Month 12 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2020 Year 11 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Pregabalin dosage, analgesic effect (numerical rating scale), adverse reaction (dizziness, somnolence, dry mouth, edema, weight gain), and clinical laboratory values such as total protein, serum albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, blood urea nitrogen, serum creatinine, and C-reactive protein are collected to evaluate clinical responses during this study.


Management information

Registered date

2016 Year 10 Month 26 Day

Last modified on

2020 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028276


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name