Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Primary Purpose
Pruritus With Chronic Liver Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Nalfurafine Hydrochloride (TRK-820)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus With Chronic Liver Disease
Eligibility 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
Sites / Locations
- Toray Industries, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00638495
Brief Title
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Official Title
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Toray Industries, Inc
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus With Chronic Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nalfurafine Hydrochloride (TRK-820)
Other Intervention Name(s)
REMITCH
Intervention Description
TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is to be administered orally once daily, after supper in principle, for 28 days.
Primary Outcome Measure Information:
Title
Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Toray Industries, Inc
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-8555
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
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