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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: |
EUCTR2005-005481-36-PT |
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Date of registration:
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14/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Alfuzosin in Uretheric Stones - ALF-STONE
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Scientific title:
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Alfuzosin in Uretheric Stones - ALF-STONE |
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Date of first enrolment:
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22/06/2006 |
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Target sample size:
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220 |
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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:2005-005481-36 |
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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: no
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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Portugal
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Age 18 or more
Patients with imagiologic evidence of uretheric stones
Informed signed consent to participate in the study.
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:
Women pregnant or breast feeding
Patients with renal impairment (creatinine > 2mg/dl)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Uretheric Stones
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Intervention(s)
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Trade Name: Benestan OD
Product Name: Alfuzosine hydrochloride
Pharmaceutical Form: Tablet
INN or Proposed INN: Alfuzosine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to E.S.W.L., namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.
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Secondary Objective: To assess the effect of Alfuzosin compared with placebo on the outcome of patients with uretheric stones submitted to E.S.W.L., namely in the percentage of patients without imagiologic evidence of any stone after the first 24 hours and at 7th day.
To assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to E.S.W.L., namely in the percentage of patients with clinical evidence of stones clearance after 72h to 96 hours (or at 48h, according with phase 2 design).
To evaluate pain (Mankoski Pain Scale) in patients treated with Alfuzosin versus those who received placebo, over a period of 7 days, after E.S.W.L.
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Primary end point(s):
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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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