This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
418
Change from Baseline to 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)
Time frame: Baseline, Week 12
Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline in the FFI Activity Limitation Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline in the FFI Pain Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline in the FFI Total Score
Time frame: Baseline, up to Day 85
Number of Participants That Used Rescue Analgesic Medication
Time frame: Up to Day 85
Amount of (milligrams [mg]) Rescue Analgesic Medication Used
Time frame: Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Score
Time frame: Up to Day 85
Clinician Global Impression of Change (CGIC) Score
Time frame: Up to Day 85
Subject Satisfaction Score
Time frame: Up to Day 85
Change from Baseline in Nodule Consistency (Firmness)
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Endo Site 42
Mesa, Arizona, United States
Endo Site 64
Scottsdale, Arizona, United States
Endo Site 11
Tucson, Arizona, United States
Endo Site 49
Castro Valley, California, United States
Endo Site 39
Cerritos, California, United States
Endo Site 31
Corona, California, United States
Endo Clinical Site 2
Encinitas, California, United States
Endo Site 8
Fresno, California, United States
Endo Site 28
Lancaster, California, United States
Endo Site 9
Los Angeles, California, United States
...and 56 more locations
Time frame: Baseline, up to Day 85
Change from Baseline in the Nodular Hardness of the Treated Nodules
Time frame: Up to Day 85