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NCT07759362
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
Conditions: Flexible Hammertoe, Semi-flexible Hammertoe
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 554
Sponsor: Endo USA Inc., a Keenova Therapeutics Company
Summary
The primary purpose of this study is to assess the efficacy, safety, and tolerability of KN3835 compared to placebo in the treatment of flexible/semi-flexible HMT.
Eligibility Criteria
Key Inclusion Criteria:
* Has 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 or study required evaluations.
* If female, be of non-childbearing potential or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after treatment.
* Be willing and able to comply with all protocol required visits and assessments.
Key Exclusion Criteria:
* Has any musculoskeletal, 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 any significant medical condition(s), which in the investigator's opinion would make the participant unsuitable for enrollment in the study.
* Has previously participated in clinical studies of KN3835 for plantar fasciitis, plantar fibromatosis, or HMT.
Note: Other inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07759362). StuddyBuddy aggregates publicly available trial information.