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

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Plantar Fasciitis

Treatments: Biological: EN3835; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06169319

EN3835-227

Details and patient eligibility

About

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

Enrollment: 231 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 3 patient groups, including a placebo group

Group 1: EN3835

Experimental group

Description:

Participants will receive EN3835 Dose 1.

Treatment:

Biological: EN3835

Group 2: EN3835

Experimental group

Description:

Participants will receive EN3835 Dose 2.

Treatment:

Biological: EN3835

Group 3: Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo.

Treatment:

Other: Placebo