UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029717
Receipt number 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 13:58:31

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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 or person

Institute

School of pharmacy, Showa University

Institute

Department

Personal name



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

Value
https://center6.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