A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)
- Registration Number
- NCT06169319
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: EN3835 EN3835 Participants will receive EN3835 Dose 1. Group 3: Placebo Placebo Participants will receive matching placebo. Group 2: EN3835 EN3835 Participants will receive EN3835 Dose 2.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from Baseline up to Day 85 in the FFI Pain Subscale Score Baseline, up to Day 85 Patient Global Impression of Change (PGIC) Foot Pain Scale Score Up to Day 85 Change from Baseline up to Day 85 in the FFI Activity Limitation 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 Foot Function Index (FFI) Difficulty Subscale 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 Subject Satisfaction with Treatment Scale Score 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 Clinician Global Impression of Change (CGIC) Scale Score Up to Day 85
Trial Locations
- Locations (39)
Endo Site 23
🇺🇸Stonecrest, Georgia, United States
Endo Site 35
🇺🇸Shreveport, Louisiana, United States
Endo Site 19
🇺🇸Grand Rapids, Michigan, United States
Endo Site 33
🇺🇸Overland Park, Kansas, United States
Endo Site 24
🇺🇸Burleson, Texas, United States
Endo Site 14
🇺🇸Sweetwater, Florida, United States
Endo Clinical Site 1
🇺🇸Georgetown, Texas, United States
Endo Site 7
🇺🇸Lawrenceville, Georgia, United States
Endo Site 11
🇺🇸Fresno, California, United States
Endo Site 32
🇺🇸Newport News, Virginia, United States
Endo Site 27
🇺🇸Missoula, Montana, United States
Endo Site 20
🇺🇸Castro Valley, California, United States
Endo Site 30
🇺🇸Fort Worth, Texas, United States
Endo Site 38
🇺🇸Westwood, New Jersey, United States
Endo Site 25
🇺🇸Moore, Oklahoma, United States
Endo Site 36
🇺🇸Malvern, Pennsylvania, United States
Endo Site 10
🇺🇸Tarzana, California, United States
Endo Clinical Site 4
🇺🇸Bedford, Texas, United States
Endo Site 17
🇺🇸Dallas, Texas, United States
Endo Site 18
🇺🇸Dallas, Texas, United States
Endo Site 39
🇺🇸Portland, Oregon, United States
Endo Site 9
🇺🇸McAllen, Texas, United States
Endo Site 16
🇺🇸Los Angeles, California, United States
Endo Site 40
🇺🇸Los Angeles, California, United States
Endo Site 28
🇺🇸O'Fallon, Illinois, United States
Endo Site 26
🇺🇸Dallas, Texas, United States
Endo Site 15
🇺🇸Houston, Texas, United States
Endo Site 22
🇺🇸San Antonio, Texas, United States
Endo Site 34
🇺🇸San Antonio, Texas, United States
Endo Clinical Site 5
🇺🇸Salt Lake City, Utah, United States
Endo Site 8
🇺🇸Tucson, Arizona, United States
Endo Site 6
🇺🇸Encinitas, California, United States
Endo Site 13
🇺🇸Corona, California, United States
Endo Site 37
🇺🇸Coconut Creek, Florida, United States
Endo Site 21
🇺🇸San Francisco, California, United States
Endo Clinical Site 3
🇺🇸Pinellas Park, Florida, United States
Endo Site 31
🇺🇸North Chicago, Illinois, United States
Endo Clinical Site 2
🇺🇸Pasadena, Maryland, United States
Endo Site 12
🇺🇸Suffolk, Virginia, United States