Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis - Full Text View

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

This study is currently recruiting participants.

Verified by WellSpan Health, September 2008

First Received: September 26, 2008 Last Updated: September 29, 2008 History of Changes

Sponsor:	WellSpan Health
Information provided by:	WellSpan Health
ClinicalTrials.gov Identifier:	NCT00762424

Purpose

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.

Condition	Intervention
Kidney Stone	Drug: Flowmax Drug: placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by WellSpan Health:

Primary Outcome Measures:

Rate and time of stone passage [ Designated as safety issue: No ]

Secondary Outcome Measures:

Level of pain [ Designated as safety issue: No ]

Estimated Enrollment:	107
Study Start Date:	June 2007

Arms	Assigned Interventions
Tamsulosin: Active Comparator	Drug: Flowmax 0.4 mg once a day until stone passage total = 9 tablets
Placebo: Placebo Comparator	Drug: placebo cornstarch

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762424

Contacts

Contact: Marc Pollack, MD, PhD	717-851-2450	mpollack@wellspan.org
Contact: Barbie Stahlman, MS	717-851-4104	bstahlman@wellspan.org

Locations

United States, Pennsylvania
York Hospital Emergency Department	Recruiting
York, Pennsylvania, United States, 17405
Contact: Marc Pollack, MD, PhD 717-851-2450 mpollack@wellspan.org
Contact: Barbie Stahlman, MS 717-851-4104 bstahlman@wellspan.org

Sponsors and Collaborators

WellSpan Health

Investigators

Principal Investigator:

Marc Pollack, MD, PhD

WellSpan Health

More Information

No publications provided

Responsible Party:	WellSpan Health ( Marc Pollack, MD, PhD Director of Emergency Medicine Research )
Study ID Numbers:	0607030
Study First Received:	September 26, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00762424 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by WellSpan Health:

Kidney stone
Ureterolithiasis
Tamsulosin
Flowmax
Emergency Department

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Urolithiasis
Physiological Effects of Drugs
Ureteral Calculi
Ureteral Diseases
Adrenergic alpha-Antagonists

Calculi
Pharmacologic Actions
Ureterolithiasis
Urologic Diseases
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists
Kidney Diseases
Nephrolithiasis
Kidney Calculi

ClinicalTrials.gov processed this record on February 08, 2010