Tamsulosin for Urolithiasis in the Emergency Dept (STONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00382265|
Recruitment Status : Completed
First Posted : September 29, 2006
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients.
Based on encouraging results from several small European clinical studies, the researchers hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis will enhance stone passage, and reduce both the time to recovery and the need for surgical intervention or lithotripsy. The researchers will conduct a study by identifying and recruiting patients presenting with urolithiasis in the emergency departments of four institutions.
A total of 500 consenting subjects will be randomly assigned to one of two groups:
- tamsulosin for a maximum of 28 days;
- placebo for a maximum of 28 days.
In addition, both groups will receive standard analgesic therapy.
The study team, which will be blinded to treatment status, will monitor each subject's clinical progress and outcome. The primary objectives of this study are:
- to determine if tamsulosin is effective, and
- to evaluate the safety of the therapy.
Another objective is to identify the most appropriate clinical subgroup(s) for treatment.
If the therapeutic benefits observed in smaller clinical studies are replicated, administration of these medications should produce several benefits, including:
- a reduction in time to pain free recovery and hence a more rapid return to employment;
- decreased requirements for narcotic analgesia;
- less need for urological out-patient clinic follow-up;
- decreased need for surgical intervention or lithotripsy; and
- substantial cost savings.
If this therapy is beneficial, it will represent a major advance in the treatment of urolithiasis. This objective is a major stated goal of the NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Clinical Urology Program, which has a stated mission to improve the treatment of urolithiasis.
Kidney stones are a major public health issue, and one person in eight will be affected by the disease. If the hypothesis is verified, the researchers will provide the first medical therapy ever for this disease. This therapy, if effective, will reduce the amount of time a patient is off work because of the pain from the disease, and may also reduce the need for expensive and time-consuming surgical treatments.
|Condition or disease||Intervention/treatment||Phase|
|Ureterolithiases||Drug: tamsulosin Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||512 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of Tamsulosin for Urolithiasis in the Emergency Department|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||February 1, 2017|
Active Comparator: Tamsulosin
Tamsulosin 0.4mg PO qd for 28 days
tamsulosin 0.4mg po qd for 28 days
Placebo Comparator: Placebo
Placebo PO qd for 28 days
placebo po qd for 28 days
- Proportion of Patients Passing Their Stone Within 28 Days by Self Report [ Time Frame: 28 days ]Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.
- Any Pain Medication [ Time Frame: 28 days ]Patients on any pain medication at day 28
- Need for Surgical Intervention [ Time Frame: 28 days ]
- Crossover to Open Label Tamsulosin [ Time Frame: 28 days ]
- Confirmation of Stone Passage on CT [ Time Frame: 28 days ]
- Return to Work (if Employed) [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382265
|United States, Alabama|
|University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35249|
|United States, District of Columbia|
|The George Washington University Medical Center|
|Washington, District of Columbia, United States, 20037|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Andrew C Meltzer, MD||The George Washington University|