MedTrace Logo

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

NCT00638495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-02-01

No results posted yet for this study

Summary

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.

Conditions

  • Pruritus With Chronic Liver Disease

Interventions

DRUG

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Toray Industries, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00638495 on ClinicalTrials.gov