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Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis

Phase 2
Waitlist Available
Research Sponsored by Endo Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
Do you have at least one hard, firm nodule on the sole of your foot?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) to days 15, 29, 43, 57

Summary

This trial is testing EN3835 to see if it can help people with plantar fibromatosis by reducing the lumps on their feet. The goal is to make walking easier and less painful for these patients.

Eligible Conditions
  • Plantar Fibroma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Do not start using orthotics or inserts specifically designed to treat plantar fibromatosis during the study period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) to days 15, 29, 43, 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to days 15, 29, 43, 57 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change between EN3835 and placebo in the Foot Function Index (FFI) pain subscale
Secondary study objectives
Change in the proportion of EN3835-treated participants and those receiving only placebo reporting a 7-point scale Clinician Global Impression of Change Scale
Mean Change with EN3835 and placebo in the FFI pain subscale
Mean change between EN3835 and placebo in the nodular hardness of the treated nodules by durometer measurement
+5 more

Side effects data

From 2021 Phase 3 trial • 153 Patients • NCT04170296
93%
Injection site bruising
79%
Injection site pain
33%
Injection site discolouration
19%
Injection site pruritus
18%
Injection site swelling
7%
Injection site mass
7%
Injection site nodule
7%
Injection site oedema
3%
Post-inflammatory pigmentation change
3%
Injection site haemorrhage
1%
Oropharyngeal pain
1%
Injection site dermatitis
1%
Urinary tract infection
1%
Blood potassium increased
1%
Nitrite urine present
1%
Pyrexia
1%
Coronavirus test positive
1%
Urine leukocyte esterase positive
1%
White blood cell count increased
1%
Diffuse alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Buttocks
Cohort 1: Posterolateral Thigh

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EN3835 GroupExperimental Treatment1 Intervention
Participant will receive a maximum dose of up to 1.8mg of EN3835 injection
Group II: Placebo GroupPlacebo Group1 Intervention
Participant will receive a maximum dose of up to 1.8mg of Placebo injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EN3835
2019
Completed Phase 3
~1770

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
135 Previous Clinical Trials
33,524 Total Patients Enrolled
Nina GreenStudy DirectorEndo Pharmaceuticals
1 Previous Clinical Trials
145 Total Patients Enrolled
~44 spots leftby Dec 2025
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