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This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EN3835 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EN3835 | Biological | Biologic: EN3835 injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score | Baseline, up to Day 85 | |
| Change from Baseline 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 |
|---|---|---|
| Louis Ortega | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endo Site 42 | Mesa | Arizona | 85210 | United States | ||
| Endo Site 64 |
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| Other |
Placebo injection |
|
| Change from Baseline in the FFI Pain Subscale Score | Baseline, up to Day 85 |
| Change from Baseline in the FFI Total Score | Baseline, up to Day 85 |
| Number of Participants That Used Rescue Analgesic Medication | Up to Day 85 |
| Amount of (milligrams [mg]) Rescue Analgesic Medication Used | Up to Day 85 |
| Patient Global Impression of Change (PGIC) Foot Pain Score | Up to Day 85 |
| Clinician Global Impression of Change (CGIC) Score | Up to Day 85 |
| Subject Satisfaction Score | Up to Day 85 |
| Change from Baseline in Nodule Consistency (Firmness) | Baseline, up to Day 85 |
| Change from Baseline in the Nodular Hardness of the Treated Nodules | Up to Day 85 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Endo Site 11 | Tucson | Arizona | 85712 | United States |
| Endo Site 49 | Castro Valley | California | 94546 | United States |
| Endo Site 39 | Cerritos | California | 90703 | United States |
| Endo Site 31 | Corona | California | 92882 | United States |
| Endo Clinical Site 2 | Encinitas | California | 92024 | United States |
| Endo Site 8 | Fresno | California | 93710 | United States |
| Endo Site 28 | Lancaster | California | 93534 | United States |
| Endo Site 9 | Los Angeles | California | 90010 | United States |
| Endo Site 53 | Los Angeles | California | 90063 | United States |
| Endo Site 50 | San Francisco | California | 94115 | United States |
| Endo Site 29 | Sherman Oaks | California | 91403 | United States |
| Endo Site 30 | Tarzana | California | 91356 | United States |
| Endo Site 61 | Torrance | California | 90502 | United States |
| Endo Site 47 | Johnstown | Colorado | 80534 | United States |
| Endo Site 65 | Parker | Colorado | 80134 | United States |
| Endo Site 17 | Westminster | Colorado | 80031 | United States |
| Endo Site 22 | Hialeah | Florida | 33013 | United States |
| Endo Site 59 | Jacksonville | Florida | 32209 | United States |
| Endo Site 23 | Miami | Florida | 33126 | United States |
| Endo Site 26 | Miami | Florida | 33156 | United States |
| Endo Site 21 | Miami | Florida | 33184 | United States |
| Endo Site 35 | North Miami Beach | Florida | 33169 | United States |
| Endo Site 19 | Palm Beach Gardens | Florida | 33410 | United States |
| Endo Clinical Site 1 | Pinellas Park | Florida | 33782 | United States |
| Endo Site 14 | Plantation | Florida | 33317 | United States |
| Endo Site 60 | Sweetwater | Florida | 33172 | United States |
| Endo Site 33 | Virginia Gardens | Florida | 33166 | United States |
| Endo Site 24 | Lawrenceville | Georgia | 30043 | United States |
| Endo Site 27 | O'Fallon | Illinois | 62269 | United States |
| Endo Site 45 | Oak Brook | Illinois | 60523 | United States |
| Endo Site 54 | Overland Park | Kansas | 66211 | United States |
| Endo Site 56 | Shreveport | Louisiana | 71101 | United States |
| Endo Site 5 | Pasadena | Maryland | 21122 | United States |
| Endo Site 16 | Grand Rapids | Michigan | 49525 | United States |
| Endo Site 12 | Jefferson City | Missouri | 65109 | United States |
| Endo Site 51 | Billings | Montana | 59101 | United States |
| Endo Site 36 | Missoula | Montana | 59804 | United States |
| Endo Site 34 | Oradell | New Jersey | 07649 | United States |
| Endo Site 62 | Vineland | New Jersey | 08360 | United States |
| Endo Site 15 | Durham | North Carolina | 27704 | United States |
| Endo Site 20 | Wilmington | North Carolina | 28412 | United States |
| Endo Site 63 | Oklahoma City | Oklahoma | 73102 | United States |
| Endo Site 10 | Altoona | Pennsylvania | 16602 | United States |
| Endo Site 44 | Malvern | Pennsylvania | 19355 | United States |
| Endo Site 38 | State College | Pennsylvania | 16801 | United States |
| Endo Site 48 | Arlington | Texas | 76015 | United States |
| Endo Site 3 | Bedford | Texas | 76021 | United States |
| Endo Site 43 | Burleson | Texas | 76028 | United States |
| Endo Site 25 | Dallas | Texas | 75208 | United States |
| Endo Site32 | Fort Worth | Texas | 76104 | United States |
| Endo Site 7 | Georgetown | Texas | 78628 | United States |
| Endo Site 55 | Houston | Texas | 77027 | United States |
| Endo Site 40 | Humble | Texas | 77338 | United States |
| Endo Site 4 | McAllen | Texas | 78501 | United States |
| Endo Site 46 | San Antonio | Texas | 78224 | United States |
| Endo Site 18 | San Antonio | Texas | 78251 | United States |
| Endo Site 37 | San Antonio | Texas | 78258 | United States |
| Endo Site 41 | Bountiful | Utah | 84010 | United States |
| Endo Site 6 | Salt Lake City | Utah | 84107 | United States |
| Endo Site 52 | Falls Church | Virginia | 22042 | United States |
| Endo Site 13 | Suffolk | Virginia | 23434 | United States |
| Endo Site 70 | Mayagüez | 00680 | Puerto Rico |
| Endo Site 68 | Mayagüez | 00682 | Puerto Rico |
| Endo Site 69 | Ponce | 00716 | Puerto Rico |
| ID | Term |
|---|---|
| D000071380 | Fibromatosis, Plantar |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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