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Due to frequent turnover of research coordinators and thus poor study accrual.
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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.
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flomax | Experimental | Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. |
|
| Sugar pill | Placebo Comparator | Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flomax | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Passage of Stone Fragments | Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging. | 2 weeks and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Evaluation | Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures. | 2 weeks and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ogan, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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Patient recruitment took place in a medical clinic affiliated with a teaching hospital from May 2005 through February 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flomax | Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. |
| FG001 | Sugar Pill | Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flomax | Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. |
| BG001 | Sugar Pill | Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Passage of Stone Fragments | Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging. | No analysis was conducted. | Posted | 2 weeks and 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flomax | Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Ogan | Emory University | 404-778-4898 | kogan@emory.edu |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Sugar pill | Drug | Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Medical Evaluation | Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures. | Posted | 2 weeks and 3 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sugar Pill | Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. | 0 | 0 | 0 | 0 |
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| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002241 | Carbohydrates |