Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382265
Status:
COMPLETED
Last Update Posted:
2018-12-10
First Post:
2006-09-28
Brief Title:
Tamsulosin for Urolithiasis in the Emergency Dept
Sponsor:
Andrew Meltzer
Organization:
George Washington University
Study Overview
Official Title:
Study of Tamsulosin for Urolithiasis in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STONE
Brief Summary:
Urolithiasis is a disease that effects 12 of the population and its incidence is growing In the US there are over 11 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
1 tamsulosin for a maximum of 28 days
2 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 subjects clinical progress and outcome The primary objectives of this study are
1 to determine if tamsulosin is effective and
2 to evaluate the safety of the therapy
Another objective is to identify the most appropriate clinical subgroups for treatment
If the therapeutic benefits observed in smaller clinical studies are replicated administration of these medications should produce several benefits including
1 a reduction in time to pain free recovery and hence a more rapid return to employment
2 decreased requirements for narcotic analgesia
3 less need for urological out-patient clinic follow-up
4 decreased need for surgical intervention or lithotripsy and
5 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
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
1 tamsulosin for a maximum of 28 days
2 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 subjects clinical progress and outcome The primary objectives of this study are
1 to determine if tamsulosin is effective and
2 to evaluate the safety of the therapy
Another objective is to identify the most appropriate clinical subgroups for treatment
If the therapeutic benefits observed in smaller clinical studies are replicated administration of these medications should produce several benefits including
1 a reduction in time to pain free recovery and hence a more rapid return to employment
2 decreased requirements for narcotic analgesia
3 less need for urological out-patient clinic follow-up
4 decreased need for surgical intervention or lithotripsy and
5 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U34DK090957 | NIH | None | httpsreporternihgovquickSearchU34DK090957 |
| U01DK096037 | NIH | None | None |
| U01DK071603 | NIH | None | None |