Trial Outcomes & Findings for Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis (NCT NCT00762424)
NCT ID: NCT00762424
Last Updated: 2014-12-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
10 Days
Results posted on
2014-12-17
Participant Flow
Participant milestones
| Measure |
Tamsulosin
Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
|
Placebo
placebo: cornstarch
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Baseline characteristics by cohort
| Measure |
Tamsulosin
n=28 Participants
Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
|
Placebo
n=25 Participants
placebo: cornstarch
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 years
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 DaysUpon 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.
Outcome measures
| Measure |
Tamsulosin
n=28 Participants
Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
|
Placebo
n=25 Participants
placebo: cornstarch
|
|---|---|---|
|
Time of Stone Passage
|
68.8 hours
Interval 0.0 to 78.0
|
19.0 hours
Interval 0.0 to 60.0
|
Adverse Events
Tamsulosin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Barbara Stahlman MS, Clinical Research Associate
WellSpan Health
Phone: 717-851-2450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place