Trial Outcomes & Findings for SaliPen Human Factors Study for OTC Labeling (NCT NCT05058430)
NCT ID: NCT05058430
Last Updated: 2024-01-09
Results Overview
Following the standard norms for the Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-diagnose the condition and to decide that treatment with the product is appropriate for them.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
One hour
Results posted on
2024-01-09
Participant Flow
Patients visiting the participating clinic were asked to participate in the study sequentially (by order of recall or arrival at the clinic). For Phase I, enrollment was stopped once the goal of eight (8) subjects with xerostomia and eight (8) subjects without xerostomia has been reached. For Phase II, 16 subjects with xerostomia that were evaluated or treated at the clinic were enrolled sequentially (by order of recall or arrival at the clinic).
Period 1 was devoted to Phase I that included 8 subjects with and 8 without xerostomia. Period 2 was devoted to Phase II that included 16 subjects with xerostomia. Eight of those participated previously in Phase II.
Participant milestones
| Measure |
Subjects With Xerostomia
Subjects complaining of xerostomia
|
Subjects Without Xerostomia
Subjects not complaining of xerostomia
|
|---|---|---|
|
Selection of the SaliPen Device
STARTED
|
8
|
8
|
|
Selection of the SaliPen Device
COMPLETED
|
8
|
8
|
|
Selection of the SaliPen Device
NOT COMPLETED
|
0
|
0
|
|
Use of the SaliPen Device
STARTED
|
16
|
0
|
|
Use of the SaliPen Device
COMPLETED
|
16
|
0
|
|
Use of the SaliPen Device
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
Baseline characteristics by cohort
| Measure |
Selection and/or Use of the SaliPen Device by Subjects With or Without Xerostomia
n=24 Participants
Phase I Subjects with and without xerostomia were requested to read the label text on the outside of the study product package (external labeling) and determine whether the study product addresses their needs, without a provider direction or assistance.
Phase II The study product was dispensed only to subjects with xerostomia. They were requested to use it with no training, except for their understanding of the User Manual (internal labeling). Those subjects used the study product in a supervised clinical setting.
|
|---|---|
|
Age, Categorical
Phase I subjects without xerostomia · <=18 years
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase I subjects without xerostomia · Between 18 and 65 years
|
7 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase I subjects without xerostomia · >=65 years
|
1 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase I subjects with xerostomia · <=18 years
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase I subjects with xerostomia · Between 18 and 65 years
|
5 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase I subjects with xerostomia · >=65 years
|
3 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase II subjects with xerostomia · <=18 years
|
0 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase II subjects with xerostomia · Between 18 and 65 years
|
13 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Categorical
Phase II subjects with xerostomia · >=65 years
|
3 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Continuous
Phase I subjects without xerostomia
|
47 years
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Continuous
Phase I subjects with xerostomia
|
58 years
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Age, Continuous
Phase II subjects with xerostomia
|
53 years
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Sex: Female, Male
Phase I subjects without xerostomia · Female
|
4 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Sex: Female, Male
Phase I subjects without xerostomia · Male
|
4 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Sex: Female, Male
Phase I subjects with xerostomia · Female
|
6 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Sex: Female, Male
Phase I subjects with xerostomia · Male
|
2 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Sex: Female, Male
Phase II subjects with xerostomia · Female
|
14 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Sex: Female, Male
Phase II subjects with xerostomia · Male
|
2 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · American Indian or Alaska Native
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · Asian
|
4 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · Black or African American
|
1 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · White
|
3 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · More than one race
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects without xerostomia · Unknown or Not Reported
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · American Indian or Alaska Native
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · Asian
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · Black or African American
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · White
|
7 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · More than one race
|
1 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase I subjects with xerostomia · Unknown or Not Reported
|
0 Participants
n=8 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · American Indian or Alaska Native
|
0 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · Asian
|
0 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · Black or African American
|
0 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · White
|
14 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · More than one race
|
2 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Race (NIH/OMB)
Phase II subjects with xerostomia · Unknown or Not Reported
|
0 Participants
n=16 Participants • The row populations differs from the overall number since 8 subjects participated in both phases. Thus, 24 subjects were recruited. Eight participated only in Phase I, 8 participated only in Phase II and 8 participated in both phases.
|
|
Xerostomia status based on self-report (suffering or not from xerostomia)
Phase I subjects without xerostomia
|
8 Participants
n=8 Participants • Overall participant number was 24. 8 (with no xerostomia) participated only in Phase I . 8 (with xerostomia) participated only in Phase II. 8 (with xerostomia) participated in both, Phase I and Phase II.
|
|
Xerostomia status based on self-report (suffering or not from xerostomia)
Phase I subjects with xerostomia
|
8 Participants
n=8 Participants • Overall participant number was 24. 8 (with no xerostomia) participated only in Phase I . 8 (with xerostomia) participated only in Phase II. 8 (with xerostomia) participated in both, Phase I and Phase II.
|
|
Xerostomia status based on self-report (suffering or not from xerostomia)
Phase II subjects with xerostomia
|
16 Participants
n=16 Participants • Overall participant number was 24. 8 (with no xerostomia) participated only in Phase I . 8 (with xerostomia) participated only in Phase II. 8 (with xerostomia) participated in both, Phase I and Phase II.
|
PRIMARY outcome
Timeframe: One hourPopulation: Eight subjects with xerostomia and 8 subjects without xerostomia
Following the standard norms for the Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-diagnose the condition and to decide that treatment with the product is appropriate for them.
Outcome measures
| Measure |
Experimental: Use of SaliPen Medical Device
n=16 Participants
Allocation to this group according to self-decision.
|
|---|---|
|
Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I]
Percentage of correct answers to the question on eligibility to use the SaliPen device
|
100 percentage
|
|
Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I]
Percentage of patients providing correct answers
|
100 percentage
|
PRIMARY outcome
Timeframe: 1.5 hourPopulation: All patients suffered from xerostomia
Correct use means that the participants will demonstrate the use of the study product according to the guidelines outlined in the User Manual. Following the standard norms for the therapy of Rx-to-OTC switch process, this outcome is a validation of potential consumers' ability to self-treat with the product according to the product's supplied IFU.
Outcome measures
| Measure |
Experimental: Use of SaliPen Medical Device
n=16 Participants
Allocation to this group according to self-decision.
|
|---|---|
|
Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II].
Percentage of correct performances
|
100 percentage
|
|
Percentage of Participants Who Correctly Will Use the Study Product When Dispensed Under Simulated OTC Conditions [Phase II].
Percentage of subjects performing correctly
|
100 percentage
|
Adverse Events
Phase I: Selection of the SaliPen Device by Subjects With or Without Xerostomia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II: Use of the SaliPen Device by Subjects With Xerostomia
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