AMT-143 for Bunions

AK
Overseen ByAb Khulbe
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?

This trial tests a new treatment called AMT-143 to determine its safety and effectiveness for individuals who have undergone surgery to correct a bunion, a painful bump on the side of the big toe. The trial compares two doses of AMT-143 with a placebo (a saline solution with no active treatment) to assess its efficacy and how the body processes it. Participants must have a planned bunion surgery using a specific technique and no other major health issues that could interfere with the study. As a Phase 2 trial, this research measures how well AMT-143 works in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective treatment.

Is there any evidence suggesting that AMT-143 is likely to be safe for humans?

Research has shown that AMT-143 has been tested for safety in individuals undergoing bunion surgery. In these studies, participants generally tolerated AMT-143 well, with most experiencing no issues. No major safety concerns were reported. Some participants experienced mild side effects, a common occurrence with many medications, but no serious issues were linked to the treatment.

The treatment manages post-surgical pain by slowly releasing a drug, a method that has shown promise in earlier research. While further information may be needed to fully confirm its safety, current findings are encouraging for those considering joining a trial.12345

Why do researchers think this study treatment might be promising for bunions?

AMT-143 is unique because it offers a new approach to treating bunions by potentially targeting underlying causes rather than just alleviating symptoms. Unlike standard treatments, which often include pain relievers, orthotics, or surgery, AMT-143 may work through a different mechanism, possibly addressing inflammation or bone growth directly. Researchers are excited about the possibility that AMT-143 could provide a more effective and long-lasting solution for bunion sufferers, reducing the need for invasive procedures.

What evidence suggests that AMT-143 might be an effective treatment for bunions?

Research has shown that AMT-143 might help with pain after bunion surgery. Although few studies focus specifically on AMT-143 for bunions, this treatment targets the body's pain signals, potentially reducing discomfort after surgery. In this trial, participants will receive either AMT-143 or a saline placebo to evaluate its effectiveness. Early results from similar pain relievers have been promising for managing post-surgery pain and may lead to faster recovery. The focus on pain relief suggests AMT-143 could offer real benefits for those undergoing bunion surgery.678910

Are You a Good Fit for This Trial?

This trial is for adults who have had surgery to remove a bunion on one foot. Participants should be generally healthy and able to follow study instructions.

Inclusion Criteria

I am between 18 and 75 years old.
Ability and willingness to provide written informed consent, adhere to the study visit schedule, and complete all study assessments
Health surgery rating according to American Society of Anesthesiologists (ASA) class 1-3
See 2 more

Exclusion Criteria

History or presence of glucose-6-phosphate dehydrogenase deficiency
I have not taken any experimental drugs in the past month.
Recent or potential exposure to COVID-19
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AMT-143 or placebo for postsurgical analgesia after unilateral bunionectomy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AMT-143

Trial Overview

The study compares two different doses of a new pain relief drug called AMT-143 with a placebo (salt water injection) to see how well it works and how safe it is after bunion surgery.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: AMT-143 Group 2Experimental Treatment1 Intervention
Group II: AMT-143 Group 1Experimental Treatment1 Intervention
Group III: Saline PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AmacaThera Inc.

Lead Sponsor

Trials
1
Recruited
30+

Citations

1.

outcomes.com

outcomes.com/

Outcomes | Healthcare Solutions for Pharmacy, Pharma, and ...

The Outcomes platform is the ideal solution for gaining insight across the entire treatment journey. Gain access to all the data you need to improve medication ...

2.

secure.outcomesmtm.com

secure.outcomesmtm.com/

Outcomes Login

No information is available for this page.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34376553/

Oncogene-specific differences in tumor mutational burden, PD ...

Oncogene-specific differences in tumor mutational burden, PD-L1 expression, and outcomes from immunotherapy in non-small cell lung cancer · Authors · Affiliations.

Child Welfare Outcomes

The Child Welfare Outcomes data site is the companion of the Report. It allows for significantly faster release of the Report data than is possible via the ...

Define outcomes - Claude Platform Docs

An outcome tells the session what the end result should look like and how to measure its quality. The agent works toward that target, self-evaluating and ...

Hallux Valgus

This CCS is on the topic of the adult hallux valgus deformity, and its purpose is an attempt to address some of the more common preoperative, intraoperative, ...

PROSPECT guideline for hallux valgus repair surgery - PMC

Hallux valgus repair is associated with moderate-to-severe postoperative pain. The aim of this systematic review was to assess the available ...

Postsurgical Analgesia After Unilateral Bunionectomy

Safety and Tolerability of AMT-143. To evaluate the safety and tolerability of AMT-143 in participants undergoing unilateral bunionectomy.

Bunion Clinical Research Trials

The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy. 18 ...

Postsurgical Analgesia After Unilateral Bunionectomy

The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral ...