Health TrialsbyHealthPanel

Phase 3 Bunionectomy Study

ConditionsPostoperative PainBunion
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCali Pharmaceuticals LLC

About this trial

Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bunion

Disqualifiers

Concomitant conditions

Trial design

Design model

Parallel

Treatments tested in this trial

  • CPL-01

    Drug

    Administration by the Surgeon during the operation

  • saline placebo

    Drug

    Administration by the Surgeon during the operation

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: CPL-01Experimental treatment 1 intervention
Group B: Saline placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain with activity

AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable)

Time frame
24 hours

Secondary outcomes

1

Postoperative Pain with rest

AUC NRS-R wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain at Rest where 0 is no pain and 10 is worst pain imaginable)

Time frame
24 hours, 72 hours
2

Postoperative rescue medication use

Opioid and non-opioid pain control medicines needed

Time frame
24 hours, 72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cali Pharmaceuticals LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: