Clinical trial NCT06169319: A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plantar Fasciitis
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score
timeFrame: Baseline, up to Day 85
measure: Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score
timeFrame: Baseline, up to Day 85
measure: Change from Baseline up to Week 12 in the Weekly Mean of the ADP Score as Measured on the Pain Intensity NRS
timeFrame: Baseline, up to Week 12
measure: Change from Baseline up to Day 85 in the FFI Pain Subscale Score
timeFrame: Baseline, up to Day 85
measure: Change from Baseline up to Day 85 in the FFI Total Score
timeFrame: Baseline, up to Day 85
measure: Number of Participants That Used Rescue Analgesic Medication
timeFrame: Up to Day 85
measure: Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used
timeFrame: Up to Day 85
measure: Patient Global Impression of Change (PGIC) Foot Pain Scale Score
timeFrame: Up to Day 85
measure: Clinician Global Impression of Change (CGIC) Scale Score
timeFrame: Up to Day 85
measure: Subject Satisfaction with Treatment Scale Score
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Endo Site 8
state: Arizona
city: Castro Valley
country: United States
facility: Endo Site 20
state: California
city: Corona
country: United States
facility: Endo Site 13
state: California
city: Encinitas
country: United States
facility: Endo Site 6
state: California
city: Fresno
country: United States
facility: Endo Site 11
state: California
city: Los Angeles
country: United States
facility: Endo Site 16
state: California
city: Los Angeles
country: United States
facility: Endo Site 40
state: California
city: San Francisco
country: United States
facility: Endo Site 21
state: California
city: Tarzana
country: United States
facility: Endo Site 10
state: California
city: Coconut Creek
country: United States
facility: Endo Site 37
state: Florida
city: Pinellas Park
country: United States
facility: Endo Clinical Site 3
state: Florida
city: Sweetwater
country: United States
facility: Endo Site 14
state: Florida
city: Lawrenceville
country: United States
facility: Endo Site 7
state: Georgia
city: Stonecrest
country: United States
facility: Endo Site 23
state: Georgia
city: North Chicago
country: United States
facility: Endo Site 31
state: Illinois
city: O'Fallon
country: United States
facility: Endo Site 28
state: Illinois
city: Overland Park
country: United States
facility: Endo Site 33
state: Kansas
city: Shreveport
country: United States
facility: Endo Site 35
state: Louisiana
city: Pasadena
country: United States
facility: Endo Clinical Site 2
state: Maryland
city: Grand Rapids
country: United States
facility: Endo Site 19
state: Michigan
city: Missoula
country: United States
facility: Endo Site 27
state: Montana
city: Westwood
country: United States
facility: Endo Site 38
state: New Jersey
city: Moore
country: United States
facility: Endo Site 25
state: Oklahoma
city: Portland
country: United States
facility: Endo Site 39
state: Oregon
city: Malvern
country: United States
facility: Endo Site 36
state: Pennsylvania
city: Bedford
country: United States
facility: Endo Clinical Site 4
state: Texas
city: Burleson
country: United States
facility: Endo Site 24
state: Texas
city: Dallas
country: United States
facility: Endo Site 17
state: Texas
city: Dallas
country: United States
facility: Endo Site 26
state: Texas
city: Dallas
country: United States
facility: Endo Site 18
state: Texas
city: Fort Worth
country: United States
facility: Endo Site 30
state: Texas
city: Georgetown
country: United States
facility: Endo Clinical Site 1
state: Texas
city: Houston
country: United States
facility: Endo Site 15
state: Texas
city: McAllen
country: United States
facility: Endo Site 9
state: Texas
city: San Antonio
country: United States
facility: Endo Site 34
state: Texas
city: San Antonio
country: United States
facility: Endo Site 22
state: Texas
city: Salt Lake City
country: United States
facility: Endo Clinical Site 5
state: Utah
city: Newport News
country: United States
facility: Endo Site 32
state: Virginia
city: Suffolk
country: United States
facility: Endo Site 12
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Luis Ortega
role: STUDY_DIRECTOR
References: