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

Toray Industries

Status and phase

Completed

Phase 2

Conditions

Pruritus With Chronic Liver Disease

Treatments

Drug: Placebo

Drug: Nalfurafine Hydrochloride (TRK-820)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00638495

820HPC01

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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