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Trial record 11 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT00448123
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Robert Swor, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Kidney Stones
Ureteral Stones
Interventions Drug: Tamsulosin
Drug: Placebo
Enrollment 127
Recruitment Details 127 subjects were enrolled in the study and 100 completed the study. Of the 27 that were excluded from analysis, 15 were excluded due to 'lost to follow-up', and another 12 had their stone removed surgically (physician decision) by the 7th day.
Pre-assignment Details  
Arm/Group Title Placebo Tamsulosin
Hide Arm/Group Description None active placebo orally per day for up to 10 days. Tamsulosin orally 0.4 mg/daily for up to 10 days.
Period Title: Overall Study
Started 62 65
Completed 47 53
Not Completed 15 12
Reason Not Completed
Lost to Follow-up             9             6
Physician Decision             6             6
Arm/Group Title Placebo Tamsulosin Total
Hide Arm/Group Description Placebo Group

Intervention - Tamsulosin

Tamsulosin: Study Drug

Total of all reporting groups
Overall Number of Baseline Participants 62 65 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 65 participants 127 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
 100.0%
65
 100.0%
127
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 65 participants 127 participants
Female
23
  37.1%
23
  35.4%
46
  36.2%
Male
39
  62.9%
42
  64.6%
81
  63.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants 65 participants 127 participants
62 65 127
1.Primary Outcome
Title Stone Passage
Hide Description Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.
Time Frame 1-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.
Arm/Group Title Placebo Tamsulosin
Hide Arm/Group Description:
Placebo Group

Intervention - Tamsulosin

Tamsulosin: Study Drug

Overall Number of Participants Analyzed 47 53
Measure Type: Number
Unit of Measure: participants
18 21
2.Secondary Outcome
Title Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge
Hide Description [Not Specified]
Time Frame 1-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.
Arm/Group Title Placebo Tamsulosin
Hide Arm/Group Description:
Active placebo orally per day for up to 10 days.
Tamsulosin orally 0.4 mg/daily for up to 10 days.
Overall Number of Participants Analyzed 29 15
Mean (Full Range)
Unit of Measure: Pain tablets
0.4
(0 to 4)
0.6
(0 to 6)
3.Secondary Outcome
Title High Pain Score by Treatment Group
Hide Description Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.
Arm/Group Title Placebo Tamsulosin
Hide Arm/Group Description:

Placebo

Placebo: Placebo

Intervention - Tamsulosin

Tamsulosin: Study Drug

Overall Number of Participants Analyzed 29 15
Mean (Full Range)
Unit of Measure: units on a scale
1.69
(0 to 7)
2.4
(0 to 8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tamsulosin
Hide Arm/Group Description Placebo Group

Intervention - Tamsulosin

Tamsulosin: Study Drug

All-Cause Mortality
Placebo Tamsulosin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tamsulosin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Tamsulosin
Affected / at Risk (%) Affected / at Risk (%)
Total   5/47 (10.64%)   4/53 (7.55%) 
Nervous system disorders     
Dizziness *  5/47 (10.64%)  4/53 (7.55%) 
*
Indicates events were collected by non-systematic assessment
Limitations of this study include non-consecutive enrollment and small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Robert Swor, DO
Organization: William Beaumont Hospital
Phone: 248-89-81970
Responsible Party: Robert Swor, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00448123     History of Changes
Other Study ID Numbers: 2005-107
First Submitted: March 13, 2007
First Posted: March 15, 2007
Results First Submitted: December 24, 2013
Results First Posted: October 12, 2016
Last Update Posted: October 12, 2016