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The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalfurafine Hydrochloride (TRK-820) | Drug | TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week]) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toray Industries, Inc | Urayasu | Chiba | 279-8555 | Japan |
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| ID | Term |
|---|---|
| C111212 | TRK 820 |
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| Placebo | Drug | Placebo is to be administered orally once daily, after supper in principle, for 28 days. |
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