UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005945
Receipt number R000006950
Scientific Title A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies
Date of disclosure of the study information 2011/07/19
Last modified on 2016/07/22 20:15:22

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Basic information

Public title

A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies

Acronym

A crossover trial of EGCS for patients with dystrophinopaties

Scientific Title

A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies

Scientific Title:Acronym

A crossover trial of EGCS for patients with dystrophinopaties

Region

Japan


Condition

Condition

Dystrophinopathies (Duchenne/Becker muscular dystrophy)

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To assess the safety and efficacy of EGCS in patients with dystrophinopaties

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Safety, motor function, CK, oxidative stress marker (pre and post of each intervention phase)

Key secondary outcomes

cTnT, TGF-beta1, IL-6


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

1st phase (12w) EGCS 5mg/kg twice/day, washout (2-4w), 2nd phase (12w) placebo twice/day

Interventions/Control_2

1st phase (12w) placebo twice/day, washout (2-4w), 2nd phase (12wa) EGCS 5mg/kg twice/day

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Genetically or immunologically diagnosed dystrophinopathies
2. Serum CK>1000 U/L
3. Written informed consent

Key exclusion criteria

1. Serious other organ disoreders (heart, respiration, liver, kidney, etc)
2. Further physiological or neurological disorders, active illness (infection, allergy, etc)
3. Past history of allergy for tea
4. Unstable general condition
5. Joining other interventional studies

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuyoshi Matsumura

Organization

National Hospital Organization Toneyama National Hospital

Division name

Neurology

Zip code


Address

Toneyama 5-1-1, Toyonaka, Osaka, Japan

TEL

06-6853-2001

Email

tmatsumura-toneyama@umin.org


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiko Tsuchie

Organization

National Hospital Organization Toneyama National Hospital

Division name

Clinical research center

Zip code


Address

Toneyama 5-1-1, Toyonaka, Osaka, Japan

TEL

06-6853-2001

Homepage URL


Email

chiken@toneyama.go.jp


Sponsor or person

Institute

National Hospital Organization Toneyama National Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Taiyo Kagaku

Name of secondary funder(s)

Taiyo Kagaku


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

独立行政法人国立病院機構刀根山病院(大阪府)
大阪バイオサイエンス研究所(大阪府)
兵庫県立大学環境人間科学部(兵庫県)
大阪大学医学部(大阪府)


Other administrative information

Date of disclosure of the study information

2011 Year 07 Month 19 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

There were no significant changes in motor function, serum CK level, and oxidative stress markers.

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

2011 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry

2016 Year 06 Month 30 Day

Date trial data considered complete

2016 Year 06 Month 30 Day

Date analysis concluded

2016 Year 09 Month 30 Day


Other

Other related information

There were no serious adverse events and the study was completed safely.


Management information

Registered date

2011 Year 07 Month 07 Day

Last modified on

2016 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006950


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name