Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Pruritus With Chronic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Nalfurafine Hydrochloride (TRK-820)

Intervention Type DRUG

TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is to be administered orally once daily, after supper in principle, for 28 days.

Interventions

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Nalfurafine Hydrochloride (TRK-820)

TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.

Intervention Type DRUG

Placebo

Placebo is to be administered orally once daily, after supper in principle, for 28 days.

Intervention Type DRUG

Other Intervention Names

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REMITCH

Eligibility Criteria

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Inclusion Criteria

* Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology.
* It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients:

Exclusion Criteria

* Malignant tumors
* Depression, integration dysfunction syndrome (schizophrenia), or dementia
* Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled
* Alcoholic liver disease
* Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study
* Allergy to opioid drugs
* Drug dependence or alcohol dependence
* Chronic renal failure

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No