Trial Outcomes & Findings for Urea for Chronic Hyponatremia (NCT NCT04588207)
NCT ID: NCT04588207
Last Updated: 2024-05-20
Results Overview
Number and percentage of participants who met inclusion/exclusion criteria and were enrolled in the study. To be assessed by analysis of enrollment data.
TERMINATED
PHASE2
2 participants
9 months
2024-05-20
Participant Flow
Participant milestones
| Measure |
On Urea, Then Off Urea
Participants assigned to this group will receive oral urea for 42 days (period 1), followed by a 10-day washout period, and then will be off urea for 42 days (period 2).
Urea: Groups "On Urea, Then Off Urea" and "Off Urea, Then On Urea" will receive urea during period 1 and period 2 of the study, respectively. The investigators will use the new American formulation of oral urea (i.e., Ure-Na™), which is packaged as a powder and mixed with 4 ounces. of water for oral consumption. Urea will be started at a dose of 15 grams of urea per mouth once daily. Dose titration will be based on the absolute increase in PNa on days 7 and 14. The urea dosing scheme will involve increasing from the starting dose of 15 grams/day to 30 grams/day (in 2 divided doses) based on the change in and absolute value of PNa, and subsequently, from 30 grams/day to 60 grams/day (in 2 divided doses) when indicated. The maximal dose of urea administered will be 60 g/day.
|
Off Urea, Then On Urea
Participants assigned to this group will be off urea during for 42 days (period 1), followed by a 10-day washout period, and then on urea for 42 days (period 2)
Urea: Groups "On Urea, Then Off Urea" and "Off Urea, Then On Urea" will receive urea during period 1 and period 2 of the study, respectively. The investigators will use the new American formulation of oral urea (i.e., Ure-Na™), which is packaged as a powder and mixed with 4 ounces. of water for oral consumption. Urea will be started at a dose of 15 grams of urea per mouth once daily. Dose titration will be based on the absolute increase in PNa on days 7 and 14. The urea dosing scheme will involve increasing from the starting dose of 15 grams/day to 30 grams/day (in 2 divided doses) based on the change in and absolute value of PNa, and subsequently, from 30 grams/day to 60 grams/day (in 2 divided doses) when indicated. The maximal dose of urea administered will be 60 g/day.
|
|---|---|---|
|
Period 1
STARTED
|
1
|
1
|
|
Period 1
COMPLETED
|
1
|
1
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
1
|
1
|
|
Washout Period
COMPLETED
|
1
|
1
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
1
|
1
|
|
Period 2
COMPLETED
|
1
|
1
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Urea for Chronic Hyponatremia
Baseline characteristics by cohort
| Measure |
On Urea, Then Off Urea
n=1 Participants
Participants assigned to this group will receive oral urea for 42 days (period 1), followed by a 10-day washout period, and then will be off urea for 42 days (period 2).
Urea: Groups "On Urea, Then Off Urea" and "Off Urea, Then On Urea" will receive urea during period 1 and period 2 of the study, respectively. The investigators will use the new American formulation of oral urea (i.e., Ure-Na™), which is packaged as a powder and mixed with 4 ounces. of water for oral consumption. Urea will be started at a dose of 15 grams of urea per mouth once daily. Dose titration will be based on the absolute increase in PNa on days 7 and 14. The urea dosing scheme will involve increasing from the starting dose of 15 grams/day to 30 grams/day (in 2 divided doses) based on the change in and absolute value of PNa, and subsequently, from 30 grams/day to 60 grams/day (in 2 divided doses) when indicated. The maximal dose of urea administered will be 60 g/day.
|
Off Urea, Then On Urea
n=1 Participants
Participants assigned to this group will be off urea during for 42 days (period 1), followed by a 10-day washout period, and then on urea for 42 days (period 2)
Urea: Groups "On Urea, Then Off Urea" and "Off Urea, Then On Urea" will receive urea during period 1 and period 2 of the study, respectively. The investigators will use the new American formulation of oral urea (i.e., Ure-Na™), which is packaged as a powder and mixed with 4 ounces. of water for oral consumption. Urea will be started at a dose of 15 grams of urea per mouth once daily. Dose titration will be based on the absolute increase in PNa on days 7 and 14. The urea dosing scheme will involve increasing from the starting dose of 15 grams/day to 30 grams/day (in 2 divided doses) based on the change in and absolute value of PNa, and subsequently, from 30 grams/day to 60 grams/day (in 2 divided doses) when indicated. The maximal dose of urea administered will be 60 g/day.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Plasma sodium concentration
|
129 mmol/L
STANDARD_DEVIATION NA • n=5 Participants
|
126 mmol/L
STANDARD_DEVIATION NA • n=7 Participants
|
127.5 mmol/L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Accuracy action boundary selection
|
32.18 percentage of accuracy
STANDARD_DEVIATION NA • n=5 Participants
|
3.45 percentage of accuracy
STANDARD_DEVIATION NA • n=7 Participants
|
17.82 percentage of accuracy
STANDARD_DEVIATION 20.3 • n=5 Participants
|
|
Score of sensorimotor ability battery
|
99.78 units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
23.45 units on a scale
STANDARD_DEVIATION NA • n=7 Participants
|
61.62 units on a scale
STANDARD_DEVIATION 54 • n=5 Participants
|
|
Sample entropy of the center of pressure data from the force plate
|
6.7 percentage
STANDARD_DEVIATION NA • n=5 Participants
|
0.2 percentage
STANDARD_DEVIATION NA • n=7 Participants
|
3.45 percentage
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Percentage angular deviation of vestibular control system using dynamic representation of upright st
|
141.57 percentage
STANDARD_DEVIATION NA • n=5 Participants
|
55.91 percentage
STANDARD_DEVIATION NA • n=7 Participants
|
98.74 percentage
STANDARD_DEVIATION 61 • n=5 Participants
|
|
Percentage angular deviation of somatosensory control system using dynamic representation of upright
|
0.05 percentage
STANDARD_DEVIATION NA • n=5 Participants
|
2.11 percentage
STANDARD_DEVIATION NA • n=7 Participants
|
1.08 percentage
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Percentage angular deviation of visual control system using dynamic representation of upright stance
|
-2.53 percentage
STANDARD_DEVIATION NA • n=5 Participants
|
-5.9 percentage
STANDARD_DEVIATION NA • n=7 Participants
|
-4.22 percentage
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Percentage weight symmetry using dynamic representation of upright stance
|
-9.49 percentage
STANDARD_DEVIATION NA • n=5 Participants
|
14.47 percentage
STANDARD_DEVIATION NA • n=7 Participants
|
2.49 percentage
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Movement latency of posture control and stability using dynamic representation of upright stance
|
4.598 msec
STANDARD_DEVIATION NA • n=5 Participants
|
8.331 msec
STANDARD_DEVIATION NA • n=7 Participants
|
6.46 msec
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Amplitude scaling of posture control and stability using dynamic representation of upright stance
|
15.922 units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
24.539 units on a scale
STANDARD_DEVIATION NA • n=7 Participants
|
20.23 units on a scale
STANDARD_DEVIATION 6 • n=5 Participants
|
|
SF-12 (Health Survey) Mental Component Summary (MCS)
|
59.77660 units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
57.92257 units on a scale
STANDARD_DEVIATION NA • n=7 Participants
|
58.85 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
|
SF-12 (Health Survey) Physical Component Summary (PCS)
|
54.83583 units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
53.79573 units on a scale
STANDARD_DEVIATION NA • n=7 Participants
|
54.32 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsNumber and percentage of participants who met inclusion/exclusion criteria and were enrolled in the study. To be assessed by analysis of enrollment data.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 9 monthsNumber and percentage of participants enrolled who completed the study. To be assessed by analysis of enrollment and completion data.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number and Percentage of Participants Enrolled Who Completed the Study
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 9 monthsNumber of participants enrolled in the study every month. To be assessed by analysis of enrollment data
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Monthly Enrollment Rate
|
0.07 participants per month
Standard Deviation 0
|
0.07 participants per month
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: The measure is only applicable when on urea
Number of prescribed urea doses taken by participants. To be assessed by records in study diary and number of returned medication doses.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number of Prescribed Urea Doses Taken by Participants
|
61.5 15-g urea packets
Interval 11.0 to 112.0
|
—
|
PRIMARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: The measure is only applicable when on urea
Reasons for non-adherence to urea therapy. To be assessed by medication acceptability and medication side effect questionnaires
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Reasons for Non-Adherence to Urea Therapy
Inconvenient medication dose frequency
|
2 Participants
|
—
|
|
Reasons for Non-Adherence to Urea Therapy
Inconvenient medication amount
|
1 Participants
|
—
|
|
Reasons for Non-Adherence to Urea Therapy
Medication is unsuitable to take outside home
|
2 Participants
|
—
|
|
Reasons for Non-Adherence to Urea Therapy
Medication tastes poorly
|
2 Participants
|
—
|
|
Reasons for Non-Adherence to Urea Therapy
Medications makes me feel sick
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Change in plasma sodium concentration from baseline to day 42. Based on plasma sodium assessments on days 0 and 42.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Plasma Sodium Concentration
|
2.5 mmol/L
Interval 0.0 to 5.0
|
0.5 mmol/L
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Change in percentage accuracy action boundary selection from baseline to day 42. This will be measured by the Perception-Action Coupling Task (PACT) which is an affordance-based assessment conducted on an iPad, which uses matched pairs of 'virtual' balls and 'virtual' holes to assess patients' ability to accurately assess their action boundaries. Accuracy of affordance perception is measured. Scores goes from 0% to 100% with higher score representing increased accuracy
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Percentage Accuracy Action Boundary Selection
|
12.965 percentage accuracy
Interval -6.25 to 32.18
|
8.245 percentage accuracy
Interval 3.45 to 13.04
|
PRIMARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Change in overall score of sensorimotor ability battery from baseline to day 42. This will be measured by the Senaptec Sensory Station™ test battery which examines separate sensorimotor elements including; multiple object tracking, reaction time, perception span, go/no go, depth perception and dynamic visual acuity. Score goes from 0 to1500 with higher scores representing better sensorimotor ability
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Overall Score of Sensorimotor Ability Battery
|
54.43 score on a scale
Interval 9.09 to 99.78
|
53.6 score on a scale
Interval 23.45 to 60.37
|
PRIMARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Measure the 'structure' of the noise in the oscillations of the center of mass of the individual. The measurement represent the percentage of displacement from the center of pressure. No reference ranges are available as these vary according to the population studied
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in the Sample Entropy of the Center of Pressure Data From the Force Plate
|
4.3 percentage change from baseline
Interval 1.9 to 6.7
|
1.3 percentage change from baseline
Interval 0.2 to 2.4
|
PRIMARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Change in percentage angular deviation of vestibular control system using dynamic representation of upright stance from baseline to day 42. This was assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the vestibular control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the vestibular system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in vestibular balance control.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Percentage Angular Deviation of Vestibular Control System Using Dynamic Representation of Upright Stance
|
112.23 percentage
Interval 82.9 to 141.57
|
88.0455 percentage
Interval 55.91 to 120.19
|
PRIMARY outcome
Timeframe: Baseline to day 42Change in percentage angular deviation of somatosensory control system using dynamic representation of upright stance from baseline to day 42. This will be assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the somatosensory control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the somatosensory system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in somatosensory balance control.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Percentage Angular Deviation of Somatosensory Control System Using Dynamic Representation of Upright Stance
|
1.99 percentage change from baseline
Interval 0.05 to 3.93
|
-0.85 percentage change from baseline
Interval -2.96 to 2.11
|
PRIMARY outcome
Timeframe: Baseline to 42 daysChange in percentage angular deviation of visual control system using dynamic representation of upright stance from baseline to day 42. This will be assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the visual control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the visual system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in visual balance control.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Percentage Angular Deviation of Visual Control System Using Dynamic Representation of Upright Stance
|
-1.1735 percentage change from baseline
Interval -2.53 to 0.19
|
-7.3825 percentage change from baseline
Interval -8.86 to -5.9
|
PRIMARY outcome
Timeframe: Baseline to day 42Change in percentage weight symmetry using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. Weight symmetry indicates weight distribution under the left and right legs prior to perturbation onset. A score of 100 indicates perfect between-limb symmetry. Larger deviations away (higher or Lower) from 100 indicate asymmetry. Scores goes from -100 to +100 closer to 100 is optimal.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Percentage Weight Symmetry Using Dynamic Representation of Upright Stance
|
-1.6255 percentage change from baseline
Interval -9.49 to 6.24
|
2.5 percentage change from baseline
Interval -9.47 to 14.47
|
PRIMARY outcome
Timeframe: Baseline to day 42Change in movement latency of posture control and stability using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. Latency scores measure the time lapse between force plate translation on postural response for healthy, elderly populations, with previously reported mean latency values ranging from 126.80-131.40. Higher/Larger scores indicate poorer balance control.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Movement Latency of Posture Control and Stability Using Dynamic Representation of Upright Stance
|
-3.8245 milliseconds
Interval -12.247 to 4.598
|
8.677 milliseconds
Interval 8.331 to 9.023
|
PRIMARY outcome
Timeframe: Baseline to day 42Change in amplitude scaling of posture control and stability using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. It is scored in units of angular momentum and normalized to body height and weight. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in ability to recover from an unexpected external translation reflecting better balance.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in Amplitude Scaling of Posture Control and Stability Using Dynamic Representation of Upright Stance
|
5.414 units on a scale
Interval -5.094 to 15.922
|
9.0495 units on a scale
Interval -6.44 to 24.539
|
PRIMARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: This measure is only relevant when on urea
Number and proportion of participants enrolled in the study with adverse events related to the use of urea from baseline to day 42. To be assessed by medication side effect questionnaire.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number and Proportion of Participants Enrolled in the Study With Adverse Events Related to the Use of Urea
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: The measure is only applicable when on urea
To be assessed by medication side effect questionnaire. A tabulation of counts of participants experiencing specific known side effects of urea as well as their intensity (mild, moderate or severe) will be performed.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Adverse Events Related to Urea
Vomiting · Severe
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Diarrhea · None
|
1 Participants
|
—
|
|
Adverse Events Related to Urea
Diarrhea · Mild
|
1 Participants
|
—
|
|
Adverse Events Related to Urea
Diarrhea · Moderate
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Diarrhea · Severe
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Headaches · None
|
1 Participants
|
—
|
|
Adverse Events Related to Urea
Headaches · Mild
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Nausea · None
|
1 Participants
|
—
|
|
Adverse Events Related to Urea
Nausea · Mild
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Nausea · Moderate
|
1 Participants
|
—
|
|
Adverse Events Related to Urea
Nausea · Severe
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Vomiting · None
|
2 Participants
|
—
|
|
Adverse Events Related to Urea
Vomiting · Mild
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Vomiting · Moderate
|
0 Participants
|
—
|
|
Adverse Events Related to Urea
Headaches · Moderate
|
1 Participants
|
—
|
|
Adverse Events Related to Urea
Headaches · Severe
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 monthsNumber of patients screened. To be assessed by analysis of screening data.
Outcome measures
| Measure |
Urea
n=1213 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number of Patients Screened
|
1213 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 monthsNumber and percentage of patients screened who met inclusion/exclusion criteria for the study. To be assessed by analysis of screening and enrollment data.
Outcome measures
| Measure |
Urea
n=1213 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number and Percentage of Patients Screened Who Met Inclusion/Exclusion Criteria for the Study
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: All participants who received at least one dose of each intervention and completed all study visits were included. The measure is only applicable when on urea.
Number and proportion of participants who took more than 80 percent of prescribed urea doses. To be assessed by analysis of study diary and number of returned medication doses.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number and Proportion of Participants Who Took More Than 80 Percent of Prescribed Urea Doses
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: All participants who received at least one dose of each intervention and completed all study visits were included
Number and proportion of participants who thought the medication was acceptable. Based on ratings for acceptability in the medication acceptability questionnaire.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Number and Proportion of Participants Who Thought the Medication Was Acceptable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 42 while taking ureaPopulation: The measure is only applicable when on urea
Average ratings using a 5-point Likert scale medication acceptability questionnaire. in which responders specify their level of agreement to a statement in five points: (1) Strongly disagree; (2) Disagree; (3) Neutral; (4) Agree; (5) Strongly agree; or (1) Very Unhappy; (2) Unhappy; (3) Neutral; (4) Happy; (5) Very Happy. A higher overall score represents more acceptability
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Average Ratings for Medication Acceptability
|
2.725 units on a 5-point Likert scale
Interval 1.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Change in SF-12 (Health Survey) Mental Component Summary (MCS) from baseline to day 42. Based on SF-12 MCS assessments on days 0 and 42. This is computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in SF-12 (Health Survey) Mental Component Summary (MCS)
|
1.435 score on SF-12 scale
Interval 0.90384 to 1.95934
|
0.745 score on SF-12 scale
Interval 0.59 to 0.90384
|
SECONDARY outcome
Timeframe: Baseline to day 42Population: All participants who received at least one dose of each intervention and completed all study visits were included
Change in SF-12 (Health Survey) Physical Component Summary (PCS) from baseline to day 42. Based on SF-12 PCS assessments on days 0 and 42. This is computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
No Urea
n=2 Participants
Number and Percentage of Participants who Met Inclusion/Exclusion Criteria and were Enrolled in the Study
|
|---|---|---|
|
Change in SF-12 (Health Survey) Physical Component Summary (PCS)
|
-2.105 score on a SF-12 scale
Interval -3.8 to -0.41
|
-3.25 score on a SF-12 scale
Interval -3.8 to -2.7
|
Adverse Events
Urea
No Urea
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Urea
n=2 participants at risk
Participants assigned to this group will receive oral urea for 42 days
|
No Urea
n=2 participants at risk
Participants assigned to this group will be off urea for 42 days
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 4 • 94 days
|
0.00%
0/2 • 94 days
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • 94 days
|
0.00%
0/2 • 94 days
|
|
Nervous system disorders
Headaches
|
50.0%
1/2 • Number of events 2 • 94 days
|
0.00%
0/2 • 94 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1 • 94 days
|
0.00%
0/2 • 94 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 3 • 94 days
|
50.0%
1/2 • Number of events 2 • 94 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 94 days
|
50.0%
1/2 • Number of events 1 • 94 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • 94 days
|
0.00%
0/2 • 94 days
|
Additional Information
Dr. Helbert Rondon Berrios, Professor of Medicine
University of Pittsburgh School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place