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Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis

NCT ID: NCT00762424

Last Updated: 2014-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-01-31

Brief Summary

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Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.

Detailed Description

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Conditions

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Kidney Stone

Keywords

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Kidney stone Ureterolithiasis Tamsulosin Flowmax Emergency Department

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tamsulosin

Group Type ACTIVE_COMPARATOR

Flowmax

Intervention Type DRUG

0.4 mg once a day until stone passage total = 9 tablets

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

cornstarch

Interventions

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Flowmax

0.4 mg once a day until stone passage total = 9 tablets

Intervention Type DRUG

placebo

cornstarch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 y.o. or older
* diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
* physician has made the decision that you will be discharged to home
* must be able to take study medication for up to 10 days and strain your urine
* must be able to keep a record of pain medication taken and complete a pain scale rating

Exclusion Criteria

* patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
* patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
* patient known to have hypersensitivity to Tamsulosin
* patient history of cataract surgery
* inability of patient to perform visual pain scale
* allergy or intolerance to acetaminophen/oxycodone
* patient is unable to understand informed consent
* prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Pollack, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

WellSpan Health

Locations

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York Hospital Emergency Department

York, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0607030

Identifier Type: -

Identifier Source: org_study_id