← Back to Search

Other

XG005 for Post-Bunionectomy Pain

Phase 2 & 3

Recruiting

Research Sponsored by Xgene Pharmaceutical Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo unilateral first metatarsal bunionectomy

Have negative urine drug screen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 30

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of two different doses of a new drug to treat bunion removal. Subjects will be monitored for 72 hours after surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of XG005 aren't listed, common risks may include allergic reactions, potential interactions with other drugs if taken outside guidelines, and typical medication side effects such as nausea or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My drug test results were negative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Summed pain intensity from end of surgery to 48 hours post-surgery

Secondary outcome measures

Continuous Pulse Oximetry

Cumulative Nausea (NNRS) assessment scores through 24 hours

Patient Global Assessment (PGA) at 48 hours

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: low doseExperimental Treatment2 Interventions

XG005 750 mg Q12 hours

Group II: high doseExperimental Treatment1 Intervention

XG005 1250 mg Q12 hours

Group III: placeboPlacebo Group1 Intervention

placebo Q12 hours

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo tablet

2020

Completed Phase 4

~6240

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xgene Pharmaceutical GroupLead Sponsor

4 Previous Clinical Trials

182 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any seniors eligible to join this experiment?

"This medical trial seeks volunteers that are between the age of majority and octogenarians."

Answered by AI

Do I meet the criteria to partake in this research?

"This medical trial is accepting applicants who are aged between 18 and 80, with acute pain as their primary symptom. 450 potential patients need to be enrolled in total."

Answered by AI

Are there vacant positions available for prospective participants in this trial?

"Per the details on clinicaltrials.gov, this research endeavour is currently seeking participants. It was posted initially on August 8th 2023 and recently updated on the 24th of same month."

Answered by AI

Are there numerous institutes administering this study in the city?

"Five medical facilities are contributing to the trial's operations, among them First Surgical Hospital in Bellaire, Legent Orthopedic Hospital in Carrollton and Memorial Hermann Village in Houston. The other two centres remain unnamed."

Answered by AI

How many individuals are taking part in this clinical investigation?

"Affirmative, the study is actively recruiting. Clinicaltrials.gov has recorded that this clinical trial was first posted on August 8th 2023 and its last update occurred on August 24th 2023. The recruitment process seeks 450 patients from 5 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

XG005 for Pain Control in Subjects Undergoing Bunionectomy

2023. "XG005 for Pain Control in Subjects Undergoing Bunionectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017999.

All > Acute Pain