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NCT05058430 · ClinicalTrials.gov registry record · NA
SaliPen Human Factors Study for OTC Labeling
A NA study of Xerostomia, sponsored by Saliwell.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05058430: Completed NA study of Xerostomia, sponsored by Saliwell.
NCT05058430 is a NA study of Xerostomia that has completed, run by Saliwell. The registered enrollment target is 24 participants, below the 93-participant average among 13 other Xerostomia trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05058430, a NA study of Xerostomia, has completed, sponsored by Saliwell.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information For User (IFU)? More specifically, this is a non-comparative case series study and is subdivided into two major parts. Those parts are: 1. Phase I: aimed at testing if, based on the IFU, the potential subjects can decide whether the study product is or is not appropriate to treat their condition and, 2. Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Electrical salivary stimulator system assigned to subjects with xerostomia
- DEVICE No Electrical salivary stimulator system assigned to subjects without xerostomia
Study Locations (1)
Indiana
- Indiana University School of Dentistry, Oral Health Research Institute - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2021-11-18 |
| Phase | NA |
What the finished NCT05058430 record still lists
NCT05058430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 93-participant average among 13 other Xerostomia trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Xerostomia appearing as the primary indexed condition, and to 2 interventions - of which Electrical salivary stimulator system assigned to subjects with xerostomia is the first listed.
NCT05058430 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05058430 about?
NCT05058430 is a clinical study titled "SaliPen Human Factors Study for OTC Labeling". This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information For User (IFU)? More specifically, this is a non-comparative case series...
What is the current status of trial NCT05058430?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2021-09-16. Estimated completion is 2021-11-18.
What conditions does trial NCT05058430 study?
This clinical trial studies the following conditions: Xerostomia.
What interventions are being tested in trial NCT05058430?
The interventions under investigation include: Electrical salivary stimulator system assigned to subjects with xerostomia (DEVICE), No Electrical salivary stimulator system assigned to subjects without xerostomia (DEVICE).
Who is sponsoring clinical trial NCT05058430?
This trial is sponsored by Saliwell, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05058430 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Xerostomia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05058430's enrollment target sits among peer trials
24 12th of 13 higher than 1 of 13 other Xerostomia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Xerostomia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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