Alfuzosin in Uretheric Stones - ALF-STONE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005481-36-PT

Enrollment

220

Registered

2006-03-14

Start date

2006-06-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uretheric Stones

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Women pregnant or breast feeding Patients with renal impairment (creatinine > 2mg/dl)

Design outcomes

Primary

Measure	Time frame
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.;Primary end point(s): ;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.	—

Measure

Time frame

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.;Primary end point(s): ;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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Countries

Portugal

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026