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Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588806
Recruitment Status : Terminated (Study halted permanently and will not resume; participants are no longer being examined or receiving intervention.)
First Posted : July 17, 2018
Results First Posted : June 4, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Collegium Pharmaceutical, Inc.
Information provided by (Responsible Party):
Ajay Wasan, MD, Msc, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Chronic Pain
Opioid Use
Deglutition
Intervention Drug: Xtampza ER (oxycodone)
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
48.5  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
11
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  27.3%
White
8
  72.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
Daily Pain Intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
8.1  (1.7)
[1]
Measure Description: Daily Pain Intensity is a measure of how intense an individual's pain was in the last 24 hours on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." Higher scores indicate higher pain levels.
Weekly Pain Intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
8.0  (2.0)
[1]
Measure Description: Weekly Pain Intensity is a measure of how intense an individual's pain was in the last 7 days on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." Higher scores indicate higher pain levels.
Swallowing Difficulty   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
6.7  (1.8)
[1]
Measure Description: Pill swallowing difficulty is a measure of how much difficulty an individual has swallowing pills on a 0-10 scale with 0 being "no trouble at all" and 10 being "the greatest difficulty possible." Higher scores indicate greater swallowing difficulty.
Opioid medication satisfaction   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
4.3  (2.8)
[1]
Measure Description: Opioid medication satisfaction is a measure of how satisfied an individual is with their current opioid medication on a 0-10 scale with 0 being "not satisfied at all" and 10 being "completely satisfied." Higher scores indicate higher satisfaction.
1.Primary Outcome
Title Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours
Hide Description Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.
Time Frame Measured at baseline and at the end of the 6-week study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent change
12.5  (31.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
2.Primary Outcome
Title Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days
Hide Description Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.
Time Frame Measured at baseline and at the end of the 6-week study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent change
9.3  (30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures
3.Secondary Outcome
Title Change in Pill Swallowing Difficulty Score
Hide Description Pill swallowing difficulty will be measured via a 0-10 scale with 0 being "no trouble at all" and 10 being "the greatest difficulty possible." Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time Frame Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.7  (2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
4.Secondary Outcome
Title Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Hide Description The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being "Not at all" and 5 being "Very much". Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time Frame Measured at baseline and at the end of the 6-week study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: T-Score
-3.6  (8.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
5.Secondary Outcome
Title Opioid Medication Satisfaction
Hide Description Opioid medication satisfaction will be measured via a 0-10 scale with 0 being "not satisfied at all" and 10 being "completely satisfied." Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).
Time Frame Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
6.Secondary Outcome
Title PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance
Hide Description The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time Frame Measured at baseline and at the end of the 6-week study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: T-Score
Depression -0.4  (7.3)
Anxiety -1.7  (6.1)
Satisfaction with Social Roles 1.1  (4.9)
Sleep Disturbance -3.7  (6.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments PROMIS Social Roles score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments PROMIS Sleep Disturbance T-Scores
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments PROMIS Depression T-Scores
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.874
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments PROMIS Anxiety T-Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
7.Secondary Outcome
Title PROMIS Physical Function
Hide Description The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being "Without any difficulty" and 1 being "Unable to do". Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).
Time Frame Measured at baseline and at the end of the 6-week study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: T-Score
0.7  (5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xtampza ER (Oxycodone) Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method ANOVA
Comments Univariate repeated measures ANOVA
8.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6).
Time Frame Recorded in week 6.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description:

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (1.1)
Time Frame 6 weeks
Adverse Event Reporting Description Standard definitions of adverse and/or serious adverse events were used.
 
Arm/Group Title Xtampza ER (Oxycodone) Treatment
Hide Arm/Group Description

Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

All-Cause Mortality
Xtampza ER (Oxycodone) Treatment
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Serious Adverse Events
Xtampza ER (Oxycodone) Treatment
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Xtampza ER (Oxycodone) Treatment
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ajay D. Wasan
Organization: University of Pittsburgh
Phone: 4126658030
EMail: wasanad@upmc.edu
Publications:
Layout table for additonal information
Responsible Party: Ajay Wasan, MD, Msc, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03588806    
Other Study ID Numbers: PRO17040444
First Submitted: May 7, 2018
First Posted: July 17, 2018
Results First Submitted: May 18, 2020
Results First Posted: June 4, 2020
Last Update Posted: June 17, 2020