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EN3835 for Plantar Fibroma (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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 85

Awards & highlights

STRIDE 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.Check my eligibility

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.See study design

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.

STRIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

STRIDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline to 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)

Secondary outcome measures

Amount of (milligrams [mg]) Rescue Analgesic Medication Used

Change from Baseline in Nodule Consistency (Firmness)

Change from Baseline in the FFI Activity Limitation Subscale Score

+8 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

Injection site oedema

Injection site nodule

Injection site mass

Injection site haemorrhage

Post-inflammatory pigmentation change

Diffuse alopecia

Urinary tract infection

Coronavirus test positive

Blood potassium increased

White blood cell count increased

Nitrite urine present

Urine leukocyte esterase positive

Oropharyngeal pain

Injection site dermatitis

Pyrexia

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Buttocks

Cohort 1: Posterolateral Thigh

STRIDE 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

~1540

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor

133 Previous Clinical Trials

32,737 Total Patients Enrolled

Luis OrtegaStudy DirectorEndo Pharmaceuticals

2 Previous Clinical Trials

901 Total Patients Enrolled

Frequently Asked Questions

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

What are the potential risks associated with EN3835 for individuals?

"As per our assessment at Power, the safety rating for EN3835 is a 3 on a scale of 1 to 3. This high score reflects the availability of data supporting both effectiveness and safety due to its Phase 3 trial status."

Answered by AI

Are patients currently able to participate in this ongoing trial?

"Affirmative. The details on clinicaltrials.gov show that this research study is actively seeking eligible participants. It was initially shared on 11/28/2023 and the most recent update was made on 2/1/2024. A total of 418 individuals are sought after, with recruitment taking place at two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

2023. "Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06151197.

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