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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00638495

Enrollment

120

Registered

2008-03-19

Start date

2008-03-31

Completion date

2009-12-31

Last updated

2010-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus With Chronic Liver Disease

Brief 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.

Interventions

DRUGNalfurafine 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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])	4 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026