Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01513161
First received: November 23, 2010
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.


Condition Intervention Phase
Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
Drug: nalfurafine hydrochloride (TRK-820)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • Change in pruritus degree measured by VAS(Visual Analogue Scale) score [ Time Frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Shiratori's severity scores assessed by the subject. [ Time Frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products) ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TRK-820 5μg
Taking TRK-820 5μg(two 2.5μg capsules) by oral route once daily for 14 days
Drug: nalfurafine hydrochloride (TRK-820)
Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary.
Active Comparator: TRK-820 2.5μg
Taking TRK-820 2.5μg(one 2.5μg capsule & one placebo capsule)by oral route once daily for 14 days
Drug: nalfurafine hydrochloride (TRK-820)
Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary.
Placebo Comparator: Placebo
Taking Placebo(two placebo capsule) by oral route once daily for 14 days
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

[At the time of obtaining the consent form]

  • Chronic renal failure patients who regularly receive hemodialysis three times a week and are not likely to have a serious treatment change or acute symptoms during the study period
  • Patients who received both of the drug pruritus treatments in section 1 and 2 below within one year before the day of singing consent form

    1. Systemic therapy of more than two consecutive weeks depending on antihistamine or antiallergic drugs falling under "prescription drugs with indication of pruritus" (oral drugs, injections, etc.)
    2. Local therapy depending on "prescription drugs with indication of pruritus" (ointment, etc.) or a moisturizer prescribed by a doctor (topical preparation, etc.)
  • Patients for whom all the conventional pruritus treatments in section (2) are not enough
  • Patients aged 20 years or older at time of signing the consent form

[At the time of enrollment]

  • Patients whose VAS scores are measured both after breakfast and dinner for five days or more of the last 7 days of the predose observation period and whose mean of whichever the higher VAS scores after breakfast or dinner is ≥50 mm
  • Patients whose whichever the higher VAS score after breakfast or dinner for the last 7 days during the preliminary observation day (measured VAS score if one is missing) is more than ≥20 mm for five days or more
  • Patients who are judged to have pruritus both during the day and at night for more than two days based on the Shiratori's severity criteria assessed by the subject at days of fifth and sixth hemodialysis and the day of hemodialysis after the completion of the predose observation period, and whose whichever the higher pruritis score measured during the day or at night is 3 (moderate) for two days or more

Exclusion Criteria:

  • Patients with malignant tumor
  • Patients with depression, schizophrenia or dementia as complications
  • Patients who currently have Child-pugh class B or C hepatic cirrhosis as complications
  • Patients with clinically significant hepatic or cardiovascular diseases which cannot be controlled by diet or drug therapy
  • Patients who currently have the following heart diseases: life-threatening arrhythmia; unstable angina or myocardiac infarction within 6 months; PCI or CABG within 6 months; NYHA class III or IV congestive heart failure
  • Patients with atopic dermatitis or chronic urticaria as complications
  • Patients who are allergic to opioid drugs
  • Patients with dependence on drug or alcohol
  • Patients who received phototherapy for pruritus within one month before signing the consent form
  • Patients who participated in the study of TRK-820 and received the study drug or who were already enrolled in this study
  • Patients who participated in other clinical studies (including the ones using artificial kidney and medical equipment), and received the study drug or treatment with clinical equipment within one month before signing the consent form
  • Pregnant women, lactating women and patients of childbearing potential who do not use contraceptive methods
  • Patients who cannot report VAS scores by their own for any reason at the principal investigator or study personnel's discretion
  • Patients whose complications or history can impact the results of this study at the principal investigator or subinvestisator's discretion
  • Other patients who are not proper to participate in this study at the principal investigator or study personnel's discretion
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513161

Locations
Korea, Republic of
SKchemicals Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Toray Industries, Inc
Investigators
Principal Investigator: Suhng Gwon Kim, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01513161     History of Changes
Other Study ID Numbers: TRK-820_PRU_III_2007
Study First Received: November 23, 2010
Last Updated: January 19, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by SK Chemicals Co.,Ltd.:
pruritus

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

ClinicalTrials.gov processed this record on September 16, 2014