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NCT03137407 · ClinicalTrials.gov registry record · Phase 2
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
A Phase 2 study of Plantar Fasciitis, sponsored by Revance Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 5
- Study locations
NCT03137407: Completed Phase 2 study of Plantar Fasciitis, sponsored by Revance Therapeutics.
NCT03137407 is a Phase 2 study of Plantar Fasciitis that has completed, run by Revance Therapeutics. The registered enrollment target is 59 participants, below the 99-participant average among 6 other Plantar Fasciitis trials with a reported enrollment target (40% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03137407, a Phase 2 study of Plantar Fasciitis, has completed, sponsored by Revance Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 5
- Study locations
Study Summary
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
Primary Outcome
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Botulinum Toxins, Type A
Study Locations (5)
Georgia
- Village Podiatry Centers - Duluth
Illinois
- Weil Foot and Ankle Institute - Des Plaines
Kansas
- Kansas City Bone & Joint Clinic - Overland Park
North Carolina
- Wake Forest Baptist Medical Center - Winston-Salem
Texas
- Element Research Group - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2018-02-20 |
| Phase | Phase 2 |
What the finished NCT03137407 record still lists
NCT03137407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 99-participant average among 6 other Plantar Fasciitis trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Plantar Fasciitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03137407 lists 5 locations in 5 states (Georgia, Illinois, Kansas).
Frequently Asked Questions
What is clinical trial NCT03137407 about?
NCT03137407 is a clinical study titled "Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis". The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
What is the current status of trial NCT03137407?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2017-06-12. Estimated completion is 2018-02-20.
What conditions does trial NCT03137407 study?
This clinical trial studies the following conditions: Plantar Fasciitis.
What interventions are being tested in trial NCT03137407?
The interventions under investigation include: Placebo (BIOLOGICAL), Botulinum Toxins, Type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT03137407?
This trial is sponsored by Revance Therapeutics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03137407 being conducted?
This trial has 5 study locations across Georgia, Illinois, Kansas, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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