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

Sponsor
Toray Industries, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00638495
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
21
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nalfurafine Hydrochloride (TRK-820)
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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.
Other Names:
  • REMITCH

    		•
    Placebo Comparator: 2

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

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toray Industries, Inc Urayasu Chiba Japan 279-8555

    Sponsors and Collaborators

    • Toray Industries, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00638495
    Other Study ID Numbers:
    • 820HPC01
    First Posted:
    Mar 19, 2008
    Last Update Posted:
    Feb 1, 2010
    Last Verified:
    Jan 1, 2010
    Additional relevant MeSH terms:
    Liver Diseases
    Pruritus

    Study Results

    No Results Posted as of Feb 1, 2010