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Completed

NCT Number: NCT00638495

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

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.

Completed

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Key information

Conditions

Pruritus With Chronic Liver Disease

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toray Industries, Inc

Urayasu, Chiba, 279-8555, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nalfurafine hydrochloride (TRK-820)

Drug

TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.

Other names: REMITCH

Placebo

Drug

Placebo is to be administered orally once daily, after supper in principle, for 28 days.

Primary outcomes

  1. Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2008
Registry last updated
Feb 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.