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EN3835 for Plantar Fibroma

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
Awards & highlights

Study Summary

This trial will study whether a new drug, EN3835, is effective and safe for treating plantar fibromatosis.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change between EN3835 and placebo in the Foot Function Index (FFI) pain subscale
Secondary outcome measures
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 oedema
7%
Injection site nodule
7%
Injection site mass
3%
Injection site haemorrhage
3%
Post-inflammatory pigmentation change
1%
Diffuse alopecia
1%
Urinary tract infection
1%
Coronavirus test positive
1%
Blood potassium increased
1%
White blood cell count increased
1%
Nitrite urine present
1%
Urine leukocyte esterase positive
1%
Oropharyngeal pain
1%
Injection site dermatitis
1%
Pyrexia
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
~1540

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
133 Previous Clinical Trials
34,819 Total Patients Enrolled
Nina GreenStudy DirectorEndo Pharmaceuticals
1 Previous Clinical Trials
145 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Virginia
Kentucky
Texas
Other
How old are they?
18 - 65
65+
What site did they apply to?
Endo Clinical Trial Site #10
Endo Clinical Trial Site #36
Endo Clinical Trial Site #30
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Endo Clinical Trial Site #36: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
2021. "Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05152173.
~53 spots leftby Apr 2025
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