UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of pregabalin for the treatment of neuropathic pain in patients undergoing hemodialysis
Title of the study (Brief title)	Efficacy and safety of pregabalin in patients undergoing hemodialysis
Region	Japan

Condition
Condition	neuropathic pain
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigated the safety and efficacy of pregabalin in patients with peripheral neuropathic pain undergoing maintenance hemodialysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS(baseline and 12 weeks)
Key secondary outcomes	SF-8,HS-CRP(baseline and 12 weeks) Blood cell counts, levels of serum creatinine, serum urea nitrogen, total protein, albumin, electrolytes, total cholesterol, low-density lipoprotein cholesterol, triglyceride, serum iron, total iron binding capacity, serum ferritin, high-sensitivity C-reactive protein, serum beta-2-microglobulin, intact parathyroid hormone Kt/V systolic and diastolic blood pressure, heart rate, cardiothoracic ratio adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	An initial dose of pregabalin at 25 mg; this was then increased up to a maximum of 150 mg.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Hemodialysis duration > 6 months at enrollment. Patients who could make a decision. Patients who were diagnosed with peripheral neuropathic pain by a neurologist.
Key exclusion criteria	(1) age < 20 years or > 85 years, (2) a history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months, (3) the presence of infectious disease, thyroid disease, malignant tumors, or treatment with steroids or immunosuppressants, (4) current hospitalization, (5) patients with a history of angioedema, and (6) patients with dementia who experience difficulty making a decision
Target sample size	30

Research contact person
Name of lead principal investigator	Masanori Abe
Organization	Nihon University School of Medicine
Division name	Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Address	30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL	0339728111
Email	abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person	Tomoyasu Otsuki
Organization	Nihon University School of Medicine
Division name	Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Address	30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL	0339728111
Homepage URL
Email	totsuki16@gmail.com

Sponsor
Institute	Nihon University School of Medicine Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nihon 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)

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	敬愛病院

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 11 Day
Last modified on	2016 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026637