Unique ID issued by UMIN | UMIN000002402 |
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Receipt number | R000002846 |
Scientific Title | Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis |
Date of disclosure of the study information | 2009/09/15 |
Last modified on | 2014/09/18 19:45:05 |
Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis
Effects of Zinc supplementation on Hyperammonemia in patients with Liver Cirrhosis (EZ trial)
Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis
Effects of Zinc supplementation on Hyperammonemia in patients with Liver Cirrhosis (EZ trial)
Japan |
Liver Cirrhosis
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the effects and safety of zinc acetate on hyperammonemia in patients with liver cirrhosis
Safety,Efficacy
Confirmatory
Explanatory
Phase III
Serum levels of ammonia (0-week and 12-week)
Adverse effects(during trial, 0-12 week)
Serum levels of BTR, psychometric testing, hepatic coma grade (0-week and 12-week)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
No need to know
2
Treatment
Medicine |
Patietns will receive 3 capsules of Nobelzin (zinc acetate, 1 capsule includes 50mg zinc) per day for 12 weeks
Patietns will receive 3 capsules of placebo per day for 12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1.Liver Cirrhosis
2.Hyperammonemia >= ULN (more than 2 times within the past 2 months)
3.Hepatic coma grade <= 2
4.Serum levels of zinc <= 65 microgram/dl
5.Ages 20 or older
6.Out-clinic patients
1.Hepatic coma grade >= 3
2.Fulminant hepatitis
3.Patients with malignant diseases who need to be treated during the period of this trial
4.Patients with cardiac, renal or pancreatic diseases who need admission for the therapy
5.Patients who are associated with heavy hematological disorders or cerebrovascular diseases
6.Known or suspected history of allergy to zinc
7.Inegible patients at a physician's discretion
50
1st name | |
Middle name | |
Last name | Kazuyuki Suzuki |
Iwate Medical University, School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
019-651-5111
ryuendo@iwate-med.ac.jp
1st name | |
Middle name | |
Last name | Ryujin Endo |
Iwate Medical University, School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
019-651-5111
ryuendo@iwate-med.ac.jp
Ministry of Health, Labour and Welfare
Research grant from the Japanese Ministry of Health, Labour and Welfare
Japan
NO
2009 | Year | 09 | Month | 15 | Day |
Published
This is the first randomized-controlled trial to show that zinc supplementation for 3 months seems effective and safe for treating hyperammonemia in liver cirrhosis.
Completed
2009 | Year | 06 | Month | 30 | Day |
2009 | Year | 09 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 07 | Month | 31 | Day |
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 09 | Month | 30 | Day |
2009 | Year | 08 | Month | 29 | Day |
2014 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002846
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