Status:
COMPLETED
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Lead Sponsor:
Toray Industries, Inc
Conditions:
Pruritus With Chronic Liver Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00638495
Start Date
March 1 2008
End Date
December 1 2009
Last Update
February 1 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Toray Industries, Inc
Urayasu, Chiba, Japan, 279-8555