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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
Biologic: Intrafascial injection
Intrafascial injection
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)
Time frame: Baseline, Week 12
Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score
Time frame: 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
Time frame: Baseline, up to Week 12
Change from Baseline up to Day 85 in the FFI Pain Subscale Score
Time frame: Baseline, up to Day 85
Change from Baseline up to Day 85 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
Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used
Time frame: Up to Day 85
Patient Global Impression of Change (PGIC) Foot Pain Scale Score
Time frame: Up to Day 85
Clinician Global Impression of Change (CGIC) Scale Score
Time frame: Up to Day 85
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Endo Site 8
Tucson, Arizona, United States
Endo Site 20
Castro Valley, California, United States
Endo Site 13
Corona, California, United States
Endo Site 6
Encinitas, California, United States
Endo Site 11
Fresno, California, United States
Endo Site 16
Los Angeles, California, United States
Endo Site 40
Los Angeles, California, United States
Endo Site 21
San Francisco, California, United States
Endo Site 10
Tarzana, California, United States
Endo Site 37
Coconut Creek, Florida, United States
...and 29 more locations
Subject Satisfaction with Treatment Scale Score
Time frame: Up to Day 85