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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: CCH High Dose | Experimental | Participants will receive a high dose of CCH on Day 1. |
|
| Group 2: CCH Low Dose | Experimental | Participants will receive a low dose of CCH on Day 1. |
|
| Group 3: Placebo | Placebo Comparator | Participants will receive matching placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Biological | Biologic: Intrafascial injection |
|
| Measure | Description | 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 |
| Measure | Description | 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 Day 85 in the FFI Activity Limitation Subscale Score | Baseline, up to Day 85 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Site 8 | Tucson | Arizona | 85712 | United States | ||
| Endo Site 20 |
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| Placebo | Biological | Intrafascial injection |
|
| 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 |
| Number of Participants That Used Rescue Analgesic Medication | 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 |
| Castro Valley |
| California |
| 94546 |
| United States |
| Endo Site 13 | Corona | California | 92882 | United States |
| Endo Site 6 | Encinitas | California | 92024 | United States |
| Endo Site 11 | Fresno | California | 93710 | United States |
| Endo Site 16 | Los Angeles | California | 90010 | United States |
| Endo Site 40 | Los Angeles | California | 90063 | United States |
| Endo Site 21 | San Francisco | California | 94115 | United States |
| Endo Site 10 | Tarzana | California | 91356 | United States |
| Endo Site 37 | Coconut Creek | Florida | 33073 | United States |
| Endo Clinical Site 3 | Pinellas Park | Florida | 33782 | United States |
| Endo Site 14 | Sweetwater | Florida | 33172 | United States |
| Endo Site 7 | Lawrenceville | Georgia | 30043 | United States |
| Endo Site 23 | Stonecrest | Georgia | 30038 | United States |
| Endo Site 31 | North Chicago | Illinois | 60064 | United States |
| Endo Site 28 | O'Fallon | Illinois | 62269 | United States |
| Endo Site 33 | Overland Park | Kansas | 66211 | United States |
| Endo Site 35 | Shreveport | Louisiana | 71101 | United States |
| Endo Clinical Site 2 | Pasadena | Maryland | 21122 | United States |
| Endo Site 19 | Grand Rapids | Michigan | 49525 | United States |
| Endo Site 27 | Missoula | Montana | 59804 | United States |
| Endo Site 38 | Westwood | New Jersey | 07675 | United States |
| Endo Site 25 | Moore | Oklahoma | 73160 | United States |
| Endo Site 39 | Portland | Oregon | 97202 | United States |
| Endo Site 36 | Malvern | Pennsylvania | 19355 | United States |
| Endo Clinical Site 4 | Bedford | Texas | 76021 | United States |
| Endo Site 24 | Burleson | Texas | 76028 | United States |
| Endo Site 17 | Dallas | Texas | 75208 | United States |
| Endo Site 26 | Dallas | Texas | 75235 | United States |
| Endo Site 18 | Dallas | Texas | 75251 | United States |
| Endo Site 30 | Fort Worth | Texas | 76104 | United States |
| Endo Clinical Site 1 | Georgetown | Texas | 78628 | United States |
| Endo Site 15 | Houston | Texas | 77027 | United States |
| Endo Site 9 | McAllen | Texas | 78501 | United States |
| Endo Site 34 | San Antonio | Texas | 78229 | United States |
| Endo Site 22 | San Antonio | Texas | 78258 | United States |
| Endo Clinical Site 5 | Salt Lake City | Utah | 84107 | United States |
| Endo Site 32 | Newport News | Virginia | 23606 | United States |
| Endo Site 12 | Suffolk | Virginia | 23434 | United States |
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
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