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NCT04319926 · ClinicalTrials.gov registry record · Phase 1
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects
A Phase 1 study of Healthy, sponsored by Scilex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04319926: Completed Phase 1 study of Healthy, sponsored by Scilex Pharmaceuticals.
NCT04319926 is a Phase 1 study of Healthy that has completed, run by Scilex Pharmaceuticals. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04319926, a Phase 1 study of Healthy, has completed, sponsored by Scilex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%
Primary Outcome
Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Conditions Studied
Interventions
- DRUG lidocaine topical system 1.8%
- DRUG lidocaine patch 5%
Study Locations (1)
Minnesota
- AXIS Clinicals - Dilworth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-09-07 |
| Est. Completion | 2018-09-09 |
| Phase | Phase 1 |
What the finished NCT04319926 record still lists
NCT04319926 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which lidocaine topical system 1.8% is the first listed.
NCT04319926 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04319926 about?
NCT04319926 is a clinical study titled "Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects". An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%
What is the current status of trial NCT04319926?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-09-07. Estimated completion is 2018-09-09.
What conditions does trial NCT04319926 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04319926?
The interventions under investigation include: lidocaine topical system 1.8% (DRUG), lidocaine patch 5% (DRUG).
Who is sponsoring clinical trial NCT04319926?
This trial is sponsored by Scilex Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04319926 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT04319926's enrollment target sits among peer trials
24 791st of 1090 higher than 254 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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