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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

This study has been terminated.
(Due to frequent turnover of research coordinators and thus poor study accrual.)
Sponsor:
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00209131
First received: September 14, 2005
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.


Condition Intervention
Urolithiasis
 Drug: Flomax
Drug: Sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Time to Passage of Stone Fragments [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: No ]
    Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.


Secondary Outcome Measures:
  • Medical Evaluation [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: Yes ]
    Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.


Enrollment: 24
Study Start Date: April 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flomax
Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
 Drug: Flomax
0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.
Other Name: Tamsulosin
Placebo Comparator: Sugar pill
Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
 Drug: Sugar pill
Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
Other Name: Placebo pill

Detailed Description:

Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

  Eligibility

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

Inclusion Criteria:

  • Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.

Exclusion Criteria:

  • Contraindications to Flomax
  • Patients with renal impairment (serum creatinine above 2.0)
  • Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
  • Use of other oral alpha blockers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209131

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kenneth Ogan, MD Emory University
  More Information

No publications provided

Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209131     History of Changes
Other Study ID Numbers: IRB ID: 128-2005
Study First Received: September 14, 2005
Results First Received: June 5, 2012
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
urolithiasis

Additional relevant MeSH terms:
Urolithiasis
Urologic Diseases
Contraceptives, Oral
Tamsulosin
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013