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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024568
Receipt No. 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

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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
Institute Department of Hospital pharmacy, Hamamatsu University School of Medicine
Institute
Department

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
URL(English) 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


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