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

NCT00638495 | Completed Phase 2

• 1 other identifier: 820HPC01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus With Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Nalfurafine Hydrochloride (TRK-820)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Also known as: REMITCH

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (1)

Toray Industries, Inc

Urayasu, Chiba, 279-8555, Japan

Location

MeSH Terms

Interventions

TRK 820

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 1, 2010

Record last verified: 2010-01

Locations

JP (1)