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Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus

NCT ID: NCT01215708

Last Updated: 2010-10-06

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

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-12-31

Brief Summary

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The investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.

Detailed Description

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Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. It´s a machine that breaks the renal stones extracorporeally. Some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. Our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.

Conditions

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Renal Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nifedipine

nifedipine retard 20mg daily

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

tamsulosin 0,4mg every night for 30 consecutive days

tamsulosin

tamsulosin 0,4mg

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

tamsulosin 0,4mg every night for 30 consecutive days

placebo

placebo capsule

Group Type PLACEBO_COMPARATOR

Tamsulosin

Intervention Type DRUG

tamsulosin 0,4mg every night for 30 consecutive days

Interventions

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Tamsulosin

tamsulosin 0,4mg every night for 30 consecutive days

Intervention Type DRUG

Other Intervention Names

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secotex

Eligibility Criteria

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Inclusion Criteria

* radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix

Exclusion Criteria

* inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo

Principal Investigators

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Miguel Srougi, MD

Role: STUDY_CHAIR

University of Sao Paulo

Locations

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Clinics Hospital of University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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278/06

Identifier Type: -

Identifier Source: org_study_id