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The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study

NCT ID: NCT00489112

Last Updated: 2007-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.

Detailed Description

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Conditions

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Distal Ureterolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Alfuzocine XL 10 mg once a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stone in the distal ureter until 1 cm of diameter

Exclusion Criteria

* Evidence of urinary tract infection or sepsis
* Moderate or severe hydronephrosis
* Acute renal failure
* Ureteral stricture
* Stone with \>1cm of diameter
* Previuos use of alpha blocker
* Pregnancy
* Previuos ureteral endoscopic or open surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Principal Investigators

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doron perez, M.D.

Role: PRINCIPAL_INVESTIGATOR

HaEmek MC

Locations

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Haemek medical center,urology department

Afula, , Israel

Site Status NOT_YET_RECRUITING

Haemek Medical Center

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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DORON PEREZ, M.D.

Role: CONTACT

[email protected]
+972-4-6495115

Facility Contacts

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doron perez, M.D.

Role: primary

[email protected]
+972-4-6495115

doron perez, MD

Role: primary

[email protected]
+972-4-6495115

Other Identifiers

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0044-07-EMC

Identifier Type: -

Identifier Source: org_study_id