← Back to Search

Other

Group 1: EN3835 for Plantar Fibroma

Phase 2
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 current foot pain due to plantar fasciitis
Have current foot pain due to plantar fasciitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 85
Awards & highlights

Study Summary

"This trial will test if two different doses of EN3835 are better than a placebo in terms of effectiveness, safety, and how well people can tolerate it."

Who is the study for?
This trial is for individuals who have had foot pain from plantar fasciitis for at least 6 months and haven't gotten better with common treatments like rest, physical therapy, or pain relievers. Participants should not have other significant foot issues that could interfere with the study.Check my eligibility
What is being tested?
The study is testing two different doses of a medication called EN3835 to see if they are effective and safe compared to a placebo (a treatment without the active drug).See study design
What are the potential side effects?
While specific side effects of EN3835 aren't listed here, common ones in trials may include injection site reactions, allergic responses, muscle or joint pain, headaches, or gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have foot pain from plantar fasciitis.
Select...
I have foot pain from plantar fasciitis.
Select...
It seems that the criterion you provided is incomplete. Could you please provide more details or clarify the criterion?

Timeline

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 at 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
Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score
Change from Baseline up to Day 85 in the FFI Pain Subscale Score
Change from Baseline up to Day 85 in the FFI Total Score
+7 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

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: EN3835Experimental Treatment1 Intervention
Participants will receive EN3835 Dose 2.
Group II: Group 1: EN3835Experimental Treatment1 Intervention
Participants will receive EN3835 Dose 1.
Group III: Group 3: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo.
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
32,930 Total Patients Enrolled
Luis OrtegaStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
1,094 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals older than 18 years being sought for participation in this research project?

"Individuals aged 18 and above, up to a maximum age of 75, are eligible for enrollment in this study according to the specified eligibility criteria."

Answered by AI

At how many distinct sites is this research trial currently being conducted?

"The ongoing clinical study is active at 5 sites, including Pinellas Park, Bedford, and Georgetown. Patients are advised to consider enrolling at the nearest location to reduce travel commitments."

Answered by AI

Has the Food and Drug Administration granted approval for Group 2: EN3835?

"The safety assessment from Power for Group 2: EN3835 in this Phase 2 trial is rated at a level of 2. This indicates that there is existing data supporting the safety aspect without evidence backing its efficacy."

Answered by AI

What is the overall participant count in this medical study?

"Indeed, information from clinicaltrials.gov indicates that this medical study is actively seeking candidates. The trial was initially posted on December 12th, 2023 and most recently revised on February 1st, 2024. It aims to recruit a total of 225 participants distributed among five different locations."

Answered by AI

Are participants being actively sought for this ongoing research study?

"Indeed, the details on clinicaltrials.gov indicate that this clinical investigation is actively seeking volunteers. Initially shared on December 12th, 2023, and last revised on February 1st, 2024, this trial aims to recruit a total of 225 participants from five distinct locations."

Answered by AI

Who else is applying?

What site did they apply to?
Endo Clinical Site 2
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)
2023. "A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169319.
All > Plantar Fasciitis > Tucson
~150 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top