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EN3835 for Plantar Fasciitis

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
Have current foot pain due to plantar fasciitis
Have current foot pain due to plantar fasciitis.
Must not have
Has a body mass index ≥35 kilograms per meter squared (kg/m^2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.
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).
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?

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My BMI is 35 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

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
~1770

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
135 Previous Clinical Trials
33,470 Total Patients Enrolled
Luis OrtegaStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
1,094 Total Patients Enrolled
~126 spots leftby Nov 2025
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