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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029717
Receipt No. R000033869
Scientific Title Evaluation of pregabalin external use preparation for diabetic polyneuropathy
Date of disclosure of the study information 2017/10/26
Last modified on 2019/02/20

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Basic information
Public title Evaluation of pregabalin external use preparation for diabetic polyneuropathy
Acronym Evaluation of pregabalin external use preparation
Scientific Title Evaluation of pregabalin external use preparation for diabetic polyneuropathy
Scientific Title:Acronym Evaluation of pregabalin external use preparation
Region
Japan

Condition
Condition diabetic polyneuropathy
Classification by specialty
Medicine in general Endocrinology and Metabolism Neurology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is evaluation of the efficacy and safety of pregabalin 5% cream for pain due to diabetic polyneuropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes amount at 8 weeks from the baseline of the average pain score
Key secondary outcomes Changes in VAS pain score from baseline measured using short version McGill pain questionnaire (SF-MPQ)
Changes in QOL score from baseline assessed with SF-8
Changes in drowsiness score from baseline assessed with ESS Japanese version

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 pregabalin 5% cream 1 g each time for one foot, twice daily application
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Adults (20 years or higher)
2) Patients who have the ability to agree, observe compliance matters while participating in the study, understand the procedure prescribed in this study plan, and can respond appropriately to all questionnaires
3) Patients with diabetic polyneuropathy(DPN) in the lower limbs during diabetes treatment
4) Patients with visual analog scale (VAS) pain score 20 mm or higher measred using the Short-Form McGill Pain Questionnaire (SF-MPQ) at screening
5) Patients who are judged eligible for study entry in the preliminary exam described in this study protocol
Key exclusion criteria 1)Patients with visual analog scale (VAS) pain score 90 mm or higher measred using the Short-Form McGill Pain Questionnaire (SF-MPQ) at screening
2) Patients who have any other severe pain unrelated to DPN which may affect the evaluation of the efficacy at screening
3) Patients with serious mental disorders at screening
4) Patients who took medication for neuropathic pain within 14 days before screening
5) Patients who has a history of allergies to medication or has a unique constitution (alcohol hypersensitivity etc.)
6) Pregnant women, lactating women
7) Those within 3 months from participation in other clinical trials
8) Others who have judged that the research responsible doctor or the research sharing doctor is inappropriate as the object of this research
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yamamoto
Organization School of Medicine, Showa University
Division name Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8000
Email tak3105@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Yoshikawa
Organization Showa University East Hospital
Division name Pharmacy
Zip code
Address 2-14-9 Nishinakanobu, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8308
Homepage URL
Email masayuki-y@cmed.showa-u.ac.jp

Sponsor
Institute School of pharmacy, Showa University
Institute
Department

Funding Source
Organization NO
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pharmacotherapeutics, Division of Pharmacokinetics and Pharmacodynamics
Showa University School of Pharmacy
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 昭和大学病院附属東病院 Showa University East Hospital

Other administrative information
Date of disclosure of the study information
2017 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 Terminated
Date of protocol fixation
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 21 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 26 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033869

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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