Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/23/2018 |
Start Date: | June 12, 2017 |
End Date: | February 20, 2018 |
A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of 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.
administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar
fasciitis.
Inclusion Criteria:
- Written informed consent, including authorization to release health information
- Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
- Persistent heel pain for more than three months
- Women of child bearing potential must have negative pregnancy test at Screening and
Injection Visits and must use an effective method of birth control during the course
of the study
Exclusion Criteria:
- Previous surgery on the midfoot or hindfoot
- Neuromuscular disease
- Systemic muscle weakness
- Planning a pregnancy during the study
- Current enrollment in an investigational drug or device study or participation in such
a study within the last 30 days prior to first visit
We found this trial at
5
sites
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