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Amitriptyline in Treating Hypoglycemia

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ClinicalTrials.gov Identifier: NCT03591458
Recruitment Status : Terminated (Slow subject enrollment, unable to complete trial in a timely manner)
First Posted : July 19, 2018
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Type1 Diabetes Mellitus
Hypoglycemia Unawareness
Interventions Drug: Amitriptyline
Drug: Placebo
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period. Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Amitriptyline Placebo Total
Hide Arm/Group Description Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period. Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period. Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
0
   0.0%
1
  50.0%
Male
0
   0.0%
1
 100.0%
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
2
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Glucose Area Under the Curve (AUC): Values < 70 mg/dL
Hide Description Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values < 70 mg/dL will be compared between the Amitriptyline and Placebo arms.
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment.
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Glucose Area Under the Curve (AUC): Values < 54 mg/dL
Hide Description Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values < 54 mg/dL will be compared between the Amitriptyline and Placebo arms.
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Ratio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes
Hide Description Participants will complete a report of all hypoglycemic events experienced during the 2-week surveillance period at the end of the Intervention Phase. The average ratio of self-reported hypoglycemic episodes to total hypoglycemic episodes recorded by Continuous Glucose Monitoring (CGM) will be compared between the Amitriptyline and Placebo arms.
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Total Count of Severe Hypoglycemic Episodes
Hide Description Severe hypoglycemic episodes, defined by the need from other to administer treatments for hypoglycemia, as reported by patients will be counted and totaled during the Intervention Phase.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Hypoglycemia Episode Count With Blood Glucose < 70 mg/dL
Hide Description Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The number of hypoglycemic episodes for glucose values < 70 mg/dL will be compared between the Amitriptyline and Placebo arms.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Hypoglycemia Episode Count With Blood Glucose < 54 mg/dL
Hide Description Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The number of hypoglycemic episodes for glucose values < 54 mg/dL will be compared between the Amitriptyline and Placebo arms.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Average Hypoglycemia Duration With Blood Glucose < 70 mg/dL
Hide Description Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The duration of hypoglycemic episodes for glucose values < 70 mg/dL will be averaged compared between the Amitriptyline and Placebo arms.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Average Hypoglycemia Duration With Blood Glucose < 54 mg/dL
Hide Description Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The duration of hypoglycemic episodes for glucose values < 54 mg/dL will be averaged compared between the Amitriptyline and Placebo arms.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Hypoglycemia Awareness Score by Gold Questionnaire
Hide Description Participants will complete the Gold questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Gold questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with scores from 1 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Gold questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Hypoglycemia Awareness Score by Clarke Questionnaire
Hide Description Participants will complete the Clarke questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Clarke questionnaire is comprised of eight questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 or 1). These scores will be summed together to a final score from 0 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Clarke questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Hypoglycemia Awareness Score by Pedersen-Bjergaard Questionnaire
Hide Description Participants will complete the Pedersen-Bjergaard questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Pederson-Bjergaard questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with answers of "Always", "sometimes", "occasionally", "never" or "Do not know". Each answer will represent an awareness status. The change in Pedersen-Bjergaard questionnaire status from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Hypoglycemia Fear Survey Score
Hide Description Participants will complete the Hypoglycemia Fear Survey for hypoglycemia fear assessment at the baseline and final Intervention Phase visit. The Hypoglycemia Fear Survey is comprised of 33 questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 to 4). These scores will be summed together to a final score from 0 to 132, representing from normal to minimal/no hypoglycemia awareness. The average change in Hypoglycemia Fear Survey questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.
Time Frame 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis conducted due to small sample size; study terminated due to low enrollment
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description:

Participants will be initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose will be increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline will be reduced to 25 mg daily during the two week Taper Period.

Amitriptyline: Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.

Participants will be initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose will be changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose will be changed back to the Placebo capsule matching the 25 mg Amitriptyline during the two week Taper period.

Placebo: Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 10 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amitriptyline Placebo
Hide Arm/Group Description Participants initiated on 25 mg Amitriptyline daily for two weeks during the Titration Period. Amitriptyline dose was increased to 50 mg daily for 8 weeks during the Intervention Period. Finally, the dose of Amitriptyline was reduced to 25 mg daily during the two week Taper Period. Participants initiated on a daily Placebo capsule matching the 25 mg Amitriptyline during the Titration Period. The daily dose was changed to the Placebo capsule matching the 50 mg Amitriptyline for 8 weeks during the Intervention Period. Finally, the daily dose was changed back to the Placebo matching the 25 mg Amitriptyline during the two week Taper Period.
All-Cause Mortality
Amitriptyline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amitriptyline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/1 (0.00%)    
Gastrointestinal disorders     
Dry Mouth * 1  1/1 (100.00%)  1 0/1 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Low
Organization: University of Utah
Phone: 801-585-1380
EMail: scott.low@hsc.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03591458     History of Changes
Other Study ID Numbers: IRB_00110853
First Submitted: July 8, 2018
First Posted: July 19, 2018
Results First Submitted: June 6, 2019
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019