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: | November 14, 2016 |
End Date: | May 31, 2017 |
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
- Skeletally mature, male or female patients 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 a negative urine pregnancy test (UPT) at
Screening Visit 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
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