Trial Outcomes & Findings for Urinalysis Results in Healthy Individuals (NCT NCT04055675)
NCT ID: NCT04055675
Last Updated: 2020-06-18
Results Overview
A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine".
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
Results posted on
2020-06-18
Participant Flow
Participant milestones
| Measure |
Asymptomatic Male Volunteers
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.
Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
|
Asymptomatic Female Volunteers
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.
Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
104
|
|
Overall Study
COMPLETED
|
96
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Urinalysis Results in Healthy Individuals
Baseline characteristics by cohort
| Measure |
Asymptomatic Male Volunteers
n=96 Participants
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.
Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
|
Asymptomatic Female Volunteers
n=104 Participants
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.
Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 21.7 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 23.6 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 23.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
104 participants
n=7 Participants
|
200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine".
Outcome measures
| Measure |
Asymptomatic Male Volunteers
n=96 Participants
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.
Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
|
Asymptomatic Female Volunteers
n=104 Participants
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.
Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
|
|---|---|---|
|
False Positive Urine
|
6 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.A urine sample with any blood on urine dipstick test will be considered to have "incidental hematuria"
Outcome measures
Outcome data not reported
Adverse Events
Asymptomatic Male Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asymptomatic Female Volunteers
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place