Postsurgical Analgesia After Unilateral Bunionectomy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAmacaThera Inc.
About this trial
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability and willingness to provide written informed consent, adhere to the study visit schedule, and complete all study assessments.
Adults 18 to 75 years at screening.
Planned distal metaphyseal osteotomy procedure (e.g., Austin procedure/chevron osteotomy) under general anesthesia.
Health surgery rating according to American Society of Anesthesiologists (ASA) class 1-3.
Disqualifiers
Surgery is for minimally invasive bunionectomy procedure.
Contralateral bunionectomy within 3 months of study dosing.
Planned surgical intervention concurrent with unilateral bunionectomy (e.g., collateral procedures).
Hypersensitivity/allergy to any ingredient in AMT-143 formulation (hyaluronan or methylcellulose).
Trial design
Design model
Parallel
Treatments tested in this trial
AMT-143
DrugGroup 1 will receive AMT-143 containing 354 mg ropivacaine.
AMT-143
DrugGroup 2 will receive AMT-143 containing 707 mg ropivacaine.
Saline (NaCl 0,9 %) (placebo)
Other interventionGroup 3 will receive 2.00 mL Placebo \[sodium chloride (NaCl) 0.9%\].
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: AMT-143 Group 1Experimental treatment 1 intervention
Group B: AMT-143 Group 2Experimental treatment 1 intervention
Group C: Saline PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability of AMT-143
To evaluate the safety and tolerability of AMT-143 in participants undergoing unilateral bunionectomy. The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) which reflect manifestations of local anesthetic (ropivacaine) systemic toxicity (LAST).
Time frame
From surgery to Day 28 follow-upSecondary outcomes
1
Analgesic Efficacy of AMT-143
To evaluate efficacy of AMT-143 for postsurgical pain management following unilateral bunionectomy. Numeric Rating Scale (NRS) pain intensity will be assessed while the participant is seated/recumbent with the surgically attended leg elevated or lying supine. The participant will be asked to rate their pain intensity on a scale of 0 to 10, where 0 = no pain and 10 = worst pain.
Time frame
From surgery to Day 28 follow-up2
Area under the plasma concentration-versus-time curve (AUC)
Time frame
From surgery to Day 28 follow-up3
Maximum observed plasma concentration (Cmax)
Time frame
From surgery to Day 28 follow-up4
Time of maximum observed plasma concentration (Tmax)
Time frame
From surgery to Day 28 follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov