Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Andrew Meltzer, George Washington University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ureterolithiases
Interventions Drug: tamsulosin
Other: Placebo
Enrollment 512
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Comparator:1 Placebo Comparator:2
Hide Arm/Group Description

Tamsulosin 0.4mg PO

tamsulosin: tamsulosin 0.4mg po qd for 28 days

Placebo

tamsulosin: tamsulosin 0.4mg po qd for 28 days

Period Title: Overall Study
Started 267 245
Completed 258 239
Not Completed 9 6
Arm/Group Title Tamsulosin Group Placebo Group Total
Hide Arm/Group Description

Tamsulosin 0.4mg PO

tamsulosin: tamsulosin 0.4mg po qd for 28 days

Placebo for 28 days Total of all reporting groups
Overall Number of Baseline Participants 267 245 512
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 267 participants 245 participants 512 participants
41.8  (13.6) 39.3  (12.9) 40.6  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 245 participants 512 participants
Female
70
  26.2%
69
  28.2%
139
  27.1%
Male
197
  73.8%
176
  71.8%
373
  72.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Non-White Race Number Analyzed 267 participants 245 participants 512 participants
56
  21.0%
54
  22.0%
110
  21.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 267 participants 245 participants 512 participants
267 245 512
1.Primary Outcome
Title Proportion of Patients Passing Their Stone Within 28 Days by Self Report
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:

Tamsulosin 0.4mg PO

tamsulosin: tamsulosin 0.4mg po qd for 28 days

Placebo

tamsulosin: tamsulosin 0.4mg po qd for 28 days

Overall Number of Participants Analyzed 258 239
Measure Type: Count of Participants
Unit of Measure: Participants
128
  49.6%
113
  47.3%
2.Secondary Outcome
Title Any Pain Medication
Hide Description Patients on any pain medication at day 28
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:

Tamsulosin 0.4mg PO

tamsulosin: tamsulosin 0.4mg po qd for 28 days

Placebo pill po qd for 28 days
Overall Number of Participants Analyzed 226 210
Measure Type: Count of Participants
Unit of Measure: Participants
22
   9.7%
24
  11.4%
3.Secondary Outcome
Title Need for Surgical Intervention
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
Tamsulosin 0.4mg po qd for 28 days
Placebo Pill qd for 28 days
Overall Number of Participants Analyzed 214 189
Measure Type: Count of Participants
Unit of Measure: Participants
14
   6.5%
13
   6.9%
4.Secondary Outcome
Title Crossover to Open Label Tamsulosin
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
Tamsulosin 0.4mg po qd for 28 days
Placebo pill po qd for 28 days
Overall Number of Participants Analyzed 214 189
Measure Type: Count of Participants
Unit of Measure: Participants
15
   7.0%
14
   7.4%
5.Secondary Outcome
Title Confirmation of Stone Passage on CT
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
Tamsulosin 0.4mg po qd for 28 days
Placebo Pill qd for 28 days
Overall Number of Participants Analyzed 122 116
Measure Type: Count of Participants
Unit of Measure: Participants
102
  83.6%
90
  77.6%
6.Secondary Outcome
Title Return to Work (if Employed)
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Control Group
Hide Arm/Group Description:
Tamsulosin 0.4mg po qd for 28 days
Placebo pill po qd for 28 days
Overall Number of Participants Analyzed 204 188
Measure Type: Count of Participants
Unit of Measure: Participants
202
  99.0%
185
  98.4%
Time Frame Adverse event data were collected for 90 days after each patient enrollment in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description Tamsulosin 0.4mg po qd for 28 days Placebo Pill po qd for 28 days
All-Cause Mortality
Tamsulosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/267 (0.00%)   0/245 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tamsulosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/267 (0.00%)   0/245 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tamsulosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/267 (0.00%)   0/245 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Meltzer, MD, MS
Organization: George Washington University
Phone: 202-741-2952
EMail: ameltzer@mfa.gwu.edu
Layout table for additonal information
Responsible Party: Andrew Meltzer, George Washington University
ClinicalTrials.gov Identifier: NCT00382265     History of Changes
Other Study ID Numbers: RO1 DK71603
U01DK096037 ( U.S. NIH Grant/Contract )
U01DK071603 ( U.S. NIH Grant/Contract )
U34DK090957 ( U.S. NIH Grant/Contract )
First Submitted: September 28, 2006
First Posted: September 29, 2006
Results First Submitted: May 1, 2018
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018