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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06169319
Other study ID # EN3835-227
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 12, 2023
Est. completion date April 2025

Study information

Verified date April 2024
Source Endo Pharmaceuticals
Contact Clinical Operations
Phone 800-462-3636
Email clinicaltrials@endo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.


Recruitment information / eligibility

Status Recruiting
Enrollment 225
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: - Have no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration. - Have a diagnosis of plantar fasciitis for =6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs). - Have current foot pain due to plantar fasciitis. Key Exclusion Criteria: - Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain. - Has a clinically meaningful laboratory abnormality. - Has a body mass index =35 kilograms per meter squared (kg/m^2). - Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
EN3835
Biologic: Intrafascial injection
Other:
Placebo
Intrafascial injection

Locations

Country Name City State
United States Endo Clinical Site 4 Bedford Texas
United States Endo Site 24 Burleson Texas
United States Endo Site 20 Castro Valley California
United States Endo Site 13 Corona California
United States Endo Site 17 Dallas Texas
United States Endo Site 18 Dallas Texas
United States Endo Site 26 Dallas Texas
United States Endo Site 6 Encinitas California
United States Endo Site 11 Fresno California
United States Endo Clinical Site 1 Georgetown Texas
United States Endo Site 19 Grand Rapids Michigan
United States Endo Site 15 Houston Texas
United States Endo Site 7 Lawrenceville Georgia
United States Endo Site 16 Los Angeles California
United States Endo Site 9 McAllen Texas
United States Endo Site 27 Missoula Montana
United States Endo Site 25 Moore Oklahoma
United States Endo Clinical Site 2 Pasadena Maryland
United States Endo Clinical Site 3 Pinellas Park Florida
United States Endo Clinical Site 5 Salt Lake City Utah
United States Endo Site 22 San Antonio Texas
United States Endo Site 21 San Francisco California
United States Endo Site 23 Stonecrest Georgia
United States Endo Site 12 Suffolk Virginia
United States Endo Site 14 Sweetwater Florida
United States Endo Site 10 Tarzana California
United States Endo Site 8 Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline, Week 12
Secondary Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score Baseline, up to Day 85
Secondary Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score Baseline, up to Day 85
Secondary Change from Baseline up to Week 12 in the Weekly Mean of the ADP Score as Measured on the Pain Intensity NRS Baseline, up to Week 12
Secondary Change from Baseline up to Day 85 in the FFI Pain Subscale Score Baseline, up to Day 85
Secondary Change from Baseline up to Day 85 in the FFI Total Score Baseline, up to Day 85
Secondary Number of Participants That Used Rescue Analgesic Medication Up to Day 85
Secondary Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used Up to Day 85
Secondary Patient Global Impression of Change (PGIC) Foot Pain Scale Score Up to Day 85
Secondary Clinician Global Impression of Change (CGIC) Scale Score Up to Day 85
Secondary Subject Satisfaction with Treatment Scale Score Up to Day 85
See also
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Unknown status NCT01882894 - Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment N/A
Completed NCT01659827 - Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis N/A
Completed NCT00888394 - Effectiveness of Podiatry on Plantar Pain Phase 4
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Terminated NCT00527748 - Foot and Ankle Range of Motion (Stretching) Apparatus N/A
Recruiting NCT05584046 - A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF N/A
Completed NCT04088383 - Amnios™ RT Outcomes Study N/A
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Completed NCT05592808 - Comparison of Taping Techniques in Plantar Fasciitis N/A
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Completed NCT02546089 - ABI v Dry Needling for Plantar Fasciitis N/A
Completed NCT00765843 - A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain N/A
Completed NCT00155324 - Change and Clinical Significance of Plantar Fascia Thickness After ESWT N/A
Completed NCT04941469 - Effectiveness of Specifically Optimized Off-the-counter Foot Orthosis for the Subtle Cavus Foot N/A
Completed NCT06055933 - Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
Recruiting NCT02539082 - the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis Phase 4
Enrolling by invitation NCT01786057 - Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis Phase 2/Phase 3