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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

Tracking Information
First Submitted Date  ICMJE March 12, 2008
First Posted Date  ICMJE March 19, 2008
Last Update Posted Date February 1, 2010
Study Start Date  ICMJE March 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week]) [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00638495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of TRK-820 Soft Capsules — Intractable Pruritus in Patients With Chronic Liver Disease —
Official Title  ICMJE Phase II Study of TRK-820 Soft Capsules — Intractable Pruritus in Patients With Chronic Liver Disease —
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pruritus With Chronic Liver Disease
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo is to be administered orally once daily, after supper in principle, for 28 days.
Study Arms
  • Experimental: 1
    Intervention: Drug: Nalfurafine Hydrochloride (TRK-820)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 18, 2008)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00638495
Other Study ID Numbers  ICMJE 820HPC01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Toray Industries, Inc, Pharmaceutical Clinical Research Dept.
Study Sponsor  ICMJE Toray Industries, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Toray Industries, Inc
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP