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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-003469-18-IT |
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Date of registration:
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15/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised, double-blind, placebo-controlled study of TRK-820 in haemodyalisis patients with uremic pruritus
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Scientific title:
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A randomised, double-blind, placebo-controlled study of TRK-820 in haemodyalisis patients with uremic pruritus |
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Date of first enrolment:
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02/12/2005 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003469-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Italy
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Lithuania
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Uremic pruritus in haemodyalisis patients
MedDRA version: 6.1
Level: SOC
Classification code 10038359
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Intervention(s)
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Product Name: nalfurafine hydrochloride
Product Code: TRK-820
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: nalfurafine hydrochloride
CAS Number: 152658-17-8
Current Sponsor code: TRK-820
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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Secondary ID(s)
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2005-003469-18-LT
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EU820UPV01
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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