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554 Participants NeededMy employer runs this trial

KN3835 for Hammer Toe

Recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Endo USA Inc., a Keenova Therapeutics Company
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MD

Medical Director, MD

Principal Investigator

Endo USA Inc., a Keenova Therapeutics Company

Are You a Good Fit for This Trial?

This trial is for people with flexible or semi-flexible hammertoe who do not have other significant foot problems. Women must not be pregnant or breastfeeding and should use effective birth control if they could become pregnant. Participants need to be able to attend all study visits.

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.
* Be willing and able to comply with all protocol required visits and assessments.
This is a key eligibility criterion for the study.
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What Are the Treatments Tested in This Trial?

Interventions

  • KN3835

Trial Overview

The study compares a new treatment called KN3835 against a placebo (inactive substance) to see how well it works and how safe it is for treating flexible/semi-flexible hammertoe. Participants are randomly assigned to receive either KN3835 or the placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: KN3835Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Endo USA Inc., a Keenova Therapeutics Company

Lead Sponsor

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