ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00638495
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : February 1, 2010
Sponsor:
Information provided by:
Toray Industries, Inc

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: REMITCH
Placebo Comparator: 2 Drug: Placebo
Placebo is to be administered orally once daily, after supper in principle, for 28 days.



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638495


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

Responsible Party: Toray Industries, Inc, Pharmaceutical Clinical Research Dept.
ClinicalTrials.gov Identifier: NCT00638495     History of Changes
Other Study ID Numbers: 820HPC01
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: January 2010

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