Plantar Fasciitis
Conditions
Brief summary
This study will assess the efficacy, safety, and tolerability of 2 different doses of collagenase clostridium histolyticum (CCH) (previously known as EN3835) compared to placebo.
Interventions
Biologic: Intrafascial injection
BIOLOGICALPlacebo
Intrafascial injection
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration. * Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs). * Have current foot pain due to plantar fasciitis. Key
Exclusion criteria
* Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain. * Has a clinically meaningful laboratory abnormality. * Has a body mass index ≥35 kilograms per meter squared (kg/m\^2). * Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline at Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS) | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score | Baseline, up to Day 85 |
| Change from Baseline up to Week 12 in the Weekly Mean of the ADP Score as Measured on the Pain Intensity NRS | Baseline, up to Week 12 |
| Change from Baseline up to Day 85 in the FFI Pain Subscale Score | Baseline, up to Day 85 |
| Change from Baseline up to Day 85 in the FFI Total Score | Baseline, up to Day 85 |
| Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score | Baseline, up to Day 85 |
| Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used | Up to Day 85 |
| Patient Global Impression of Change (PGIC) Foot Pain Scale Score | Up to Day 85 |
| Clinician Global Impression of Change (CGIC) Scale Score | Up to Day 85 |
| Subject Satisfaction with Treatment Scale Score | Up to Day 85 |
| Number of Participants That Used Rescue Analgesic Medication | Up to Day 85 |
Countries
United States
Outcome results
None listed