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Trial record 13 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis (Flowmax)

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: NCT00762424
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
WellSpan Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Kidney Stone
Interventions Drug: Flowmax
Drug: placebo
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description Flowmax: 0.4 mg once a day until stone passage total = 9 tablets placebo: cornstarch
Period Title: Overall Study
Started 28 25
Completed 28 25
Not Completed 0 0
Arm/Group Title Tamsulosin Placebo Total
Hide Arm/Group Description Flowmax: 0.4 mg once a day until stone passage total = 9 tablets placebo: cornstarch Total of all reporting groups
Overall Number of Baseline Participants 28 25 53
Hide Baseline Analysis Population Description
results not available
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>=18 years Number Analyzed 28 participants 25 participants 53 participants
28 25 53
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 53 participants
Female
11
  39.3%
10
  40.0%
21
  39.6%
Male
17
  60.7%
15
  60.0%
32
  60.4%
1.Primary Outcome
Title Time of Stone Passage
Hide Description Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.
Time Frame 10 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
placebo: cornstarch
Overall Number of Participants Analyzed 28 25
Median (Inter-Quartile Range)
Unit of Measure: hours
68.8
(0 to 78)
19.0
(0 to 60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description Flowmax: 0.4 mg once a day until stone passage total = 9 tablets placebo: cornstarch
All-Cause Mortality
Tamsulosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tamsulosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/25 (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   0/28 (0.00%)   0/25 (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
Name/Title: Barbara Stahlman MS, Clinical Research Associate
Organization: WellSpan Health
Phone: 717-851-2450
Responsible Party: WellSpan Health
ClinicalTrials.gov Identifier: NCT00762424     History of Changes
Other Study ID Numbers: 0607030
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: December 16, 2013
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014