Unique ID issued by UMIN | UMIN000005945 |
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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 |
A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies
A crossover trial of EGCS for patients with dystrophinopaties
A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies
A crossover trial of EGCS for patients with dystrophinopaties
Japan |
Dystrophinopathies (Duchenne/Becker muscular dystrophy)
Neurology |
Others
YES
To assess the safety and efficacy of EGCS in patients with dystrophinopaties
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Safety, motor function, CK, oxidative stress marker (pre and post of each intervention phase)
cTnT, TGF-beta1, IL-6
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
NO
Central registration
2
Treatment
Food |
1st phase (12w) EGCS 5mg/kg twice/day, washout (2-4w), 2nd phase (12w) placebo twice/day
1st phase (12w) placebo twice/day, washout (2-4w), 2nd phase (12wa) EGCS 5mg/kg twice/day
Not applicable |
Not applicable |
Male and Female
1. Genetically or immunologically diagnosed dystrophinopathies
2. Serum CK>1000 U/L
3. Written informed consent
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
40
1st name | |
Middle name | |
Last name | Tsuyoshi Matsumura |
National Hospital Organization Toneyama National Hospital
Neurology
Toneyama 5-1-1, Toyonaka, Osaka, Japan
06-6853-2001
tmatsumura-toneyama@umin.org
1st name | |
Middle name | |
Last name | Yoshiko Tsuchie |
National Hospital Organization Toneyama National Hospital
Clinical research center
Toneyama 5-1-1, Toyonaka, Osaka, Japan
06-6853-2001
chiken@toneyama.go.jp
National Hospital Organization Toneyama National Hospital
none
Self funding
Taiyo Kagaku
Taiyo Kagaku
NO
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)
2011 | Year | 07 | Month | 19 | Day |
Unpublished
There were no significant changes in motor function, serum CK level, and oxidative stress markers.
Completed
2011 | Year | 05 | Month | 20 | Day |
2011 | Year | 07 | Month | 01 | Day |
2016 | Year | 06 | Month | 30 | Day |
2016 | Year | 06 | Month | 30 | Day |
2016 | Year | 06 | Month | 30 | Day |
2016 | Year | 09 | Month | 30 | Day |
There were no serious adverse events and the study was completed safely.
2011 | Year | 07 | Month | 07 | Day |
2016 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006950
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