A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)

Plantar Fasciitis Clinical Trial

Official title:

A Phase 2, Double-blind, Randomized, Placebo-controlled, Dose-ranging Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fasciitis (PFA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169319
• Other study ID #: EN3835-227
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Endo Pharmaceuticals
• Contact: Clinical Operations
• Phone: 800-462-3636
• Email: clinicaltrials[@]endo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Biological:
• EN3835
Biologic: Intrafascial injection

Other:
• Placebo
Intrafascial injection

Locations

Country	Name	City	State
United States	Endo Clinical Site 4	Bedford	Texas
United States	Endo Site 24	Burleson	Texas
United States	Endo Site 20	Castro Valley	California
United States	Endo Site 13	Corona	California
United States	Endo Site 17	Dallas	Texas
United States	Endo Site 18	Dallas	Texas
United States	Endo Site 26	Dallas	Texas
United States	Endo Site 6	Encinitas	California
United States	Endo Site 11	Fresno	California
United States	Endo Clinical Site 1	Georgetown	Texas
United States	Endo Site 19	Grand Rapids	Michigan
United States	Endo Site 15	Houston	Texas
United States	Endo Site 7	Lawrenceville	Georgia
United States	Endo Site 16	Los Angeles	California
United States	Endo Site 9	McAllen	Texas
United States	Endo Site 27	Missoula	Montana
United States	Endo Site 25	Moore	Oklahoma
United States	Endo Clinical Site 2	Pasadena	Maryland
United States	Endo Clinical Site 3	Pinellas Park	Florida
United States	Endo Clinical Site 5	Salt Lake City	Utah
United States	Endo Site 22	San Antonio	Texas
United States	Endo Site 21	San Francisco	California
United States	Endo Site 23	Stonecrest	Georgia
United States	Endo Site 12	Suffolk	Virginia
United States	Endo Site 14	Sweetwater	Florida
United States	Endo Site 10	Tarzana	California
United States	Endo Site 8	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score		Baseline, up to Day 85
Secondary	Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score		Baseline, up to Day 85
Secondary	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
Secondary	Change from Baseline up to Day 85 in the FFI Pain Subscale Score		Baseline, up to Day 85
Secondary	Change from Baseline up to Day 85 in the FFI Total Score		Baseline, up to Day 85
Secondary	Number of Participants That Used Rescue Analgesic Medication		Up to Day 85
Secondary	Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used		Up to Day 85
Secondary	Patient Global Impression of Change (PGIC) Foot Pain Scale Score		Up to Day 85
Secondary	Clinician Global Impression of Change (CGIC) Scale Score		Up to Day 85
Secondary	Subject Satisfaction with Treatment Scale Score		Up to Day 85