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NCT03825315 · ClinicalTrials.gov registry record · Phase 2
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
A Phase 2 study of Plantar Fasciitis, sponsored by Revance Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
- 20
- Study locations
NCT03825315: Completed Phase 2 study of Plantar Fasciitis, sponsored by Revance Therapeutics.
NCT03825315 is a Phase 2 study of Plantar Fasciitis that has completed, run by Revance Therapeutics. The registered enrollment target is 155 participants, above the 83-participant average among 6 other Plantar Fasciitis trials with a reported enrollment target (87% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03825315, a Phase 2 study of Plantar Fasciitis, has completed, sponsored by Revance Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.
Primary Outcome
Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL DAXI 80 U
- BIOLOGICAL DAXI 120 U
Study Locations (20)
California
- Sacramento Foot and Ankle Center, Inc - Carmichael
- Bay Area Foot Care - Castro Valley
- West Coast Foot and Ankle - Huntington Beach
- Foot and Ankle Clinic - Los Angeles
- Bay Area Foot Care - San Francisco
- University Foot and Ankle Foundation - Santa Monica
Texas
- North Texas Institute of Neurology and Headache - Frisco
- Hermann Drive Research Hospital - Houston
- Futuro Clinical Trials, LLC - McAllen
- Strash Foot and Ankle Care - San Antonio
- The Podiatry Group of South Texas - San Antonio
Illinois
- Podiatry 1st - Belleville
- Rosalind Franklin University of Medicine & Science - North Chicago
Utah
- Rocky Mountain Foot and Ankle, LLC - Salt Lake City
- Wasatch Clinical Research - Salt Lake City
Arizona
- Aung Foot Health Clinic - Tucson
Florida
- LA Podiatry Group - West Palm Beach
Kansas
- Kansas Institute of Research - Overland Park
Nevada
- Advanced Foot & Ankle Center - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2020-06-04 |
| Phase | Phase 2 |
What the finished NCT03825315 record still lists
NCT03825315 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 6 other Plantar Fasciitis trials with a reported enrollment target (87% higher).
The record links to 1 condition, with Plantar Fasciitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03825315 names 20 study sites across 9 states, led by California, Texas, Illinois.
Frequently Asked Questions
What is clinical trial NCT03825315 about?
NCT03825315 is a clinical study titled "DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis". This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.
What is the current status of trial NCT03825315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2018-12-31. Estimated completion is 2020-06-04.
What conditions does trial NCT03825315 study?
This clinical trial studies the following conditions: Plantar Fasciitis.
What interventions are being tested in trial NCT03825315?
The interventions under investigation include: Placebo (OTHER), DAXI 80 U (BIOLOGICAL), DAXI 120 U (BIOLOGICAL).
Who is sponsoring clinical trial NCT03825315?
This trial is sponsored by Revance Therapeutics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03825315 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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