UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023117 |
|---|---|
| Receipt number | 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 19:38:37 |
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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
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
totsuki16@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026637
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
