- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01513161
Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis (TRK-820)
January 19, 2012 updated by: SK Chemicals Co., Ltd.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- SKchemicals Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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.)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TRK-820 5μg
Taking TRK-820 5μg(two 2.5μg capsules) by oral route once daily for 14 days
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Suhng Gwon Kim, MD, PhD, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
November 23, 2010
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 20, 2012
Last Update Submitted That Met QC Criteria
January 19, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRK-820_PRU_III_2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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