Trial Outcomes & Findings for The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients (NCT NCT00448123)

NCT ID: NCT00448123

Last Updated: 2016-10-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 127 participants
• Primary outcome timeframe: 1-7 days
• Results posted on: 2016-10-12

Participant Flow

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.

Participant milestones

Measure	Placebo None active placebo orally per day for up to 10 days.	Tamsulosin Tamsulosin orally 0.4 mg/daily for up to 10 days.
Overall Study STARTED	62	65
Overall Study COMPLETED	47	53
Overall Study NOT COMPLETED	15	12

Reasons for withdrawal

Measure	Placebo None active placebo orally per day for up to 10 days.	Tamsulosin Tamsulosin orally 0.4 mg/daily for up to 10 days.
Overall Study Lost to Follow-up	9	6
Overall Study Physician Decision	6	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=62 Participants Placebo Group	Tamsulosin n=65 Participants Intervention - Tamsulosin Tamsulosin: Study Drug	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=93 Participants	65 Participants n=4 Participants	127 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	42 Participants n=4 Participants	81 Participants n=27 Participants
Region of Enrollment United States	62 participants n=93 Participants	65 participants n=4 Participants	127 participants n=27 Participants

PRIMARY outcome

Timeframe: 1-7 days

Population: 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.

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.

Outcome measures

Measure	Placebo n=47 Participants Placebo Group	Tamsulosin n=53 Participants Intervention - Tamsulosin Tamsulosin: Study Drug
Stone Passage	18 participants	21 participants

SECONDARY outcome

Timeframe: 1-7 days

Population: 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.

Outcome measures

Measure	Placebo n=29 Participants Placebo Group	Tamsulosin n=15 Participants Intervention - Tamsulosin Tamsulosin: Study Drug
Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge	0.4 Pain tablets Interval 0.0 to 4.0	0.6 Pain tablets Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 7 Days

Population: 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.

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.

Outcome measures

Measure	Placebo n=29 Participants Placebo Group	Tamsulosin n=15 Participants Intervention - Tamsulosin Tamsulosin: Study Drug
High Pain Score by Treatment Group	1.69 units on a scale Interval 0.0 to 7.0	2.4 units on a scale Interval 0.0 to 8.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Tamsulosin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=47 participants at risk Placebo Group	Tamsulosin n=53 participants at risk Intervention - Tamsulosin Tamsulosin: Study Drug
Nervous system disorders Dizziness	10.6% 5/47	7.5% 4/53

Additional Information

Robert Swor, DO

William Beaumont Hospital

Phone: 248-89-81970

Email: raswor@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place