UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028276