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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023117
Receipt No. R000026637
Scientific Title Efficacy and safety of pregabalin for the treatment of neuropathic pain in patients undergoing hemodialysis
Date of disclosure of the study information 2016/07/11
Last modified on 2016/07/11

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Basic information
Public title Efficacy and safety of pregabalin for the treatment of neuropathic pain in patients undergoing hemodialysis
Acronym Efficacy and safety of pregabalin in patients undergoing hemodialysis
Scientific Title Efficacy and safety of pregabalin for the treatment of neuropathic pain in patients undergoing hemodialysis
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL 0339728111
Email abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyasu Otsuki
Organization Nihon University School of Medicine
Division name Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
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

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)

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 敬愛病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 11 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 02 Month 01 Day
Date of IRB
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

Other
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

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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