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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

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ClinicalTrials.gov Identifier: NCT00209131
Recruitment Status : Terminated (Due to frequent turnover of research coordinators and thus poor study accrual.)
First Posted : September 21, 2005
Results First Posted : July 9, 2012
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 21, 2005
Results First Submitted Date  ICMJE June 5, 2012
Results First Posted Date  ICMJE July 9, 2012
Last Update Posted Date October 28, 2013
Study Start Date  ICMJE April 2005
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
Time to Passage of Stone Fragments [ Time Frame: 2 weeks and 3 months ]
Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
Medical Evaluation [ Time Frame: 2 weeks and 3 months ]
Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Official Title  ICMJE Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Brief Summary 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.
Detailed Description Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urolithiasis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Flomax
  • 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.
    Intervention: Drug: Sugar pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 7, 2006)
24
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209131
Other Study ID Numbers  ICMJE 0128-2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Ogan, MD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Ogan, MD Emory University
PRS Account Emory University
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP