UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009520
Receipt number R000011182
Scientific Title Safety and efficacy of external application of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs) with renal function in patients of type 2 diabetic nephropathy
Date of disclosure of the study information 2012/12/11
Last modified on 2012/12/11 14:11:05

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Basic information

Public title

Safety and efficacy of external application of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs) with renal function in patients of type 2 diabetic nephropathy

Acronym

Effect of NSAIDs external application in type 2 diabetic nephropathy patients

Scientific Title

Safety and efficacy of external application of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs) with renal function in patients of type 2 diabetic nephropathy

Scientific Title:Acronym

Effect of NSAIDs external application in type 2 diabetic nephropathy patients

Region

Japan


Condition

Condition

Diabetic nephropathy

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The short-term influence of the external application NSAIDs for renal function in a patients of diabetic nephropathy with lumbago and an articulatio-genus pain is considered.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concentration of urinary Prostaglandin E2, serum loxoprofen(trans-OH body), estimated GFR(ml/min/m2),serum cystatin C,blood pressure and VAS(visual analogue scale).
Before and five days after consecutive external application,respectively

Key secondary outcomes



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

There was no placebo group. Only one group used loxoprofen.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients of diabetic nephropathy(from stage II to IV)
Patients with Lunbago or knee pain.

Key exclusion criteria

Patients who take NSAIDs.
Patients for less than one month after an operation.
Patients who severe liver dysfunction and severe heart failure.
The patient who has hypersensitivity to loxoprofen.
The patient of aspirin-induced asthma.

Target sample size

22


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Uzu

Organization

Shiga University of Medical Science

Division name

Internal medicine

Zip code


Address

Tsukinowa-Cho, Seta, Otsu, Shiga 520-2192, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hisazumi Araki

Organization

Shiga University of Medical Science

Division name

Internal medicine

Zip code


Address


TEL


Homepage URL


Email

haraki@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science

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



Other administrative information

Date of disclosure of the study information

2012 Year 12 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

2010 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 16 Day

Last follow-up date

2011 Year 12 Month 31 Day

Date of closure to data entry

2011 Year 12 Month 31 Day

Date trial data considered complete

2012 Year 01 Month 31 Day

Date analysis concluded

2012 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 12 Month 11 Day

Last modified on

2012 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011182


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name