Status:
COMPLETED
A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Plantar Fasciitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy, safety, and tolerability of 2 different doses of collagenase clostridium histolyticum (CCH) (previously known as EN3835) compared to placebo.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT06169319
Start Date
January 3 2024
End Date
September 30 2024
Last Update
September 30 2025
Active Locations (39)
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1
Endo Site 8
Tucson, Arizona, United States, 85712
2
Endo Site 20
Castro Valley, California, United States, 94546
3
Endo Site 13
Corona, California, United States, 92882
4
Endo Site 6
Encinitas, California, United States, 92024