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EN3835 for Plantar Fibromatosis (STRIDE Trial)
Phase 3
Recruiting
Research Sponsored by Endo Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a diagnosis of PFI.
Have current foot pain due to PFI.
Must not have
Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial will test if EN3835 is effective and safe for treating PFI (Ledderhose disease) compared to a placebo.
Who is the study for?
This trial is for adults over 18 with Ledderhose disease, which causes painful foot lumps. Participants must be able to walk and give informed consent. Women must either not be able to have children or agree to use birth control during the study.
What is being tested?
The trial is testing EN3835's effectiveness against a placebo in treating Ledderhose disease. It aims to see if EN3835 can reduce pain and improve condition without causing harm.
What are the potential side effects?
While specific side effects of EN3835 are not listed, common ones may include irritation at the injection site, allergic reactions, or general discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with primary fibromyalgia.
Select...
I have foot pain because of plantar fasciitis.
Select...
I agree not to take any prohibited medication during the study.
Select...
I agree not to take any prohibited medication during the study.
Select...
I have been diagnosed with primary fibromyalgia.
Select...
I have foot pain because of plantar fasciitis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have lumps on my foot not related to plantar fibromatosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2021 Phase 3 trial • 153 Patients • NCT0417029693%
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EN3835Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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
33,283 Total Patients Enrolled
Luis OrtegaStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
907 Total Patients Enrolled