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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urolithiasis
Interventions Drug: Flomax
Drug: Sugar pill
Enrollment 24
Recruitment Details Patient recruitment took place in a medical clinic affiliated with a teaching hospital from May 2005 through February 2009.
Pre-assignment Details  
Arm/Group Title Flomax Sugar Pill
Hide Arm/Group Description Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Period Title: Overall Study
Started 15 [1] 11 [1]
Completed 0 [2] 0 [2]
Not Completed 15 11
Reason Not Completed
Lack of personnel due to turnovers.             15             11
[1]
Patients enrolled for participation but did not complete the study.
[2]
Lack of personnel for adequate followup and data collection.
Arm/Group Title Flomax Sugar Pill Total
Hide Arm/Group Description Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. Total of all reporting groups
Overall Number of Baseline Participants 15 11 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
11
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 11 participants 26 participants
55  (5) 53  (5) 54  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 26 participants
Female
7
  46.7%
4
  36.4%
11
  42.3%
Male
8
  53.3%
7
  63.6%
15
  57.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 11 participants 26 participants
15 11 26
1.Primary Outcome
Title Time to Passage of Stone Fragments
Hide Description Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.
Time Frame 2 weeks and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was conducted.
Arm/Group Title Flomax Sugar Pill
Hide Arm/Group Description:
Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Medical Evaluation
Hide Description Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.
Time Frame 2 weeks and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flomax Sugar Pill
Hide Arm/Group Description:
Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flomax Sugar Pill
Hide Arm/Group Description Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
All-Cause Mortality
Flomax Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Flomax Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flomax Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Study was terminated due to turnovers of personnel to assist with recruitment and execution of the study.Recruitment was strained and patients recruited could not be followed up in a timely fashion to adhere to protocol. Thus, no data was generated.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kenneth Ogan
Organization: Emory University
Phone: 404-778-4898
EMail: kogan@emory.edu
Layout table for additonal information
Responsible Party: Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier: NCT00209131    
Other Study ID Numbers: 0128-2005
First Submitted: September 14, 2005
First Posted: September 21, 2005
Results First Submitted: June 5, 2012
Results First Posted: July 9, 2012
Last Update Posted: October 28, 2013