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

This study has been completed.
Sponsor:
Information provided by:
Toray Industries, Inc
ClinicalTrials.gov Identifier:
NCT00638495
First received: March 12, 2008
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Pruritus With Chronic Liver Disease
Drug: Nalfurafine Hydrochloride (TRK-820)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of TRK-820 Soft Capsules — Intractable Pruritus in Patients With Chronic Liver Disease —

Resource links provided by NLM:


Further study details as provided by Toray Industries, Inc:

Primary Outcome Measures:
  • Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week]) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: REMITCH
Placebo Comparator: 2 Drug: Placebo
Placebo is to be administered orally once daily, after supper in principle, for 28 days.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638495

Locations
Japan
Toray Industries, Inc
Urayasu, Chiba, Japan, 279-8555
Sponsors and Collaborators
Toray Industries, Inc
  More Information

No publications provided

Responsible Party: Toray Industries, Inc, Pharmaceutical Clinical Research Dept.
ClinicalTrials.gov Identifier: NCT00638495     History of Changes
Other Study ID Numbers: 820HPC01
Study First Received: March 12, 2008
Last Updated: January 28, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Liver Diseases
Pruritus
Digestive System Diseases
Signs and Symptoms
Skin Diseases
Skin Manifestations

ClinicalTrials.gov processed this record on November 27, 2014