XG005 for Post-Bunionectomy Pain

Recruiting at 7 trial locations

Overseen By Joey Chang

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Xgene Pharmaceutical Group

Must not be taking: Pain medication, Benzodiazepines, Antidepressants, Corticosteroids

Disqualifiers: HIV, Opioid dependence, Severe depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 87

Duration: 72 hours

450 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test the safety and effectiveness of XG005 pills in patients who have had bunion surgery. Patients will take either a low dose or high dose of the pill while staying in the clinic. The goal is to see if XG005 helps with recovery after surgery.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants using pain medications, certain psychiatric drugs, and other specific medications like corticosteroids, digoxin, and warfarin. It's best to discuss your current medications with the trial team to see if they are allowed.

Eligibility Criteria

This trial is for non-pregnant, non-breastfeeding individuals who are scheduled for a bunionectomy and have no drug abuse history. They must not be on certain medications like painkillers or antidepressants, have stable blood pressure or diabetes treatments, and should not have severe depression or anxiety.

Inclusion Criteria

My drug test results were negative.

I am scheduled for surgery to correct a bunion on my foot.

Non-pregnant, non-lactating

Exclusion Criteria

Medical condition or history that in the investigator's opinion could adversely impact the subject's participation or safety

You have used illegal drugs in the past.

You have had a problem with taking opioid drugs in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 750 mg XG005, 1250 mg XG005, or placebo twice a day post-surgery for 72 hours

72 hours

In-clinic confinement for 72 hours post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 days

Follow-up visit on Day 15

Treatment Details

Interventions

• XG005

Trial Overview The study tests the effectiveness of XG005 tablets in two doses (750 mg and 1250 mg) against a placebo for pain control after bunion surgery. Participants will stay at the clinic for three days post-surgery to ensure their safety and monitor results.

Participant Groups

Group I: low dose Experimental Treatment 2 Interventions

XG005 750 mg Q12 hours

Group II: high dose Experimental Treatment 1 Intervention

XG005 1250 mg Q12 hours

Group III: placebo Placebo Group 1 Intervention

placebo Q12 hours

Who Is Running the Clinical Trial?

Xgene Pharmaceutical Group

Lead Sponsor

Trials

5

Recruited

630+