Trial Outcomes & Findings for Tamsulosin for Urolithiasis in the Emergency Dept (NCT NCT00382265)

NCT ID: NCT00382265

Last Updated: 2018-12-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 512 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2018-12-10

Participant Flow

Participant milestones

Measure	Active Comparator:1 Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo Comparator:2 Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Overall Study STARTED	267	245
Overall Study COMPLETED	258	239
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tamsulosin for Urolithiasis in the Emergency Dept

Baseline characteristics by cohort

Measure	Tamsulosin Group n=267 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo Group n=245 Participants Placebo for 28 days	Total n=512 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 13.6 • n=5 Participants	39.3 years STANDARD_DEVIATION 12.9 • n=7 Participants	40.6 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	197 Participants n=5 Participants	176 Participants n=7 Participants	373 Participants n=5 Participants
Race/Ethnicity, Customized Non-White Race	56 Participants n=5 Participants	54 Participants n=7 Participants	110 Participants n=5 Participants
Region of Enrollment United States	267 participants n=5 Participants	245 participants n=7 Participants	512 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

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.

Outcome measures

Measure	Tamsulosin n=258 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo n=239 Participants Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Proportion of Patients Passing Their Stone Within 28 Days by Self Report	128 Participants	113 Participants

SECONDARY outcome

Timeframe: 28 days

Patients on any pain medication at day 28

Outcome measures

Measure	Tamsulosin n=226 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo n=210 Participants Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Any Pain Medication	22 Participants	24 Participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Tamsulosin n=214 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo n=189 Participants Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Need for Surgical Intervention	14 Participants	13 Participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Tamsulosin n=214 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo n=189 Participants Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Crossover to Open Label Tamsulosin	15 Participants	14 Participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Tamsulosin n=122 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo n=116 Participants Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Confirmation of Stone Passage on CT	102 Participants	90 Participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Tamsulosin n=204 Participants Tamsulosin 0.4mg PO tamsulosin: tamsulosin 0.4mg po qd for 28 days	Placebo n=188 Participants Placebo tamsulosin: tamsulosin 0.4mg po qd for 28 days
Return to Work (if Employed)	202 Participants	185 Participants

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

Andrew Meltzer, MD, MS

George Washington University

Phone: 202-741-2952

Email: ameltzer@mfa.gwu.edu

Results disclosure agreements

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