XG005 for Post-Bunionectomy Pain

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, XG005, to evaluate its safety and effectiveness in managing pain after bunion surgery compared to a placebo (a pill with no active drug). Participants will receive either a low dose, a high dose, or a placebo to determine which best reduces pain. People scheduled for bunion surgery who have not recently used certain medications or drugs might be suitable for this study. Participants must stay in the clinic for three days after surgery for safety monitoring. As a Phase 2 trial, this study measures how well XG005 works in an initial, smaller group, offering participants a chance to contribute to important pain management research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that XG005 is promising as a non-opioid pain reliever. Studies have found it reduces pain after surgery without the use of opioids. In earlier studies, patients experienced significantly less pain after taking XG005, suggesting its effectiveness for managing pain after bunion surgery.

Regarding safety, past research hasn't identified any major side effects. Patients have tolerated the treatment well. Researchers continue to monitor for any possible side effects as they gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for post-bunionectomy pain?

Unlike the standard of care for post-bunionectomy pain, which often involves NSAIDs or opioids, XG005 offers a potential new approach with its unique mechanism of action. Researchers are excited about XG005 because it targets pain pathways differently, potentially providing effective relief without the side effects commonly associated with opioids. Additionally, the trial explores two dosing options—750 mg and 1250 mg every 12 hours—allowing for flexibility in managing pain intensity. This innovative approach could lead to more personalized and effective pain management strategies for patients recovering from bunion surgery.

What evidence suggests that XG005 might be an effective treatment for post-bunionectomy pain?

Research shows that XG005 helps reduce pain after surgery. In this trial, participants will receive either a high dose or a low dose of XG005, or a placebo, which contains no active medicine. Earlier studies found that patients who took XG005 reported significantly less pain than those who took a placebo. Specifically, for bunion surgery, the pain relief was both noticeable and significant. Additionally, a substantial difference in pain levels occurred over the first 48 hours after surgery between those who took XG005 and those who took the placebo. This suggests that XG005 could be an effective non-opioid option for managing post-surgical pain. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/xgenes-non-opioid-analgesic-reduces-pain-in-phase-iib-trial/

Xgene's non-opioid analgesic reduces pain in Phase IIb trial

A trial with XG005 met it's primary and secondary endpoints, demonstrating a statistically significant reduction in post-surgery pain ...

2.

lotuscr.com

lotuscr.com/positive-topline-results-of-xgenes-non-opioid-product-for-post-surgical-pain/

Positive topline results of Xgene's non-opioid product for ...

The trial showed that XG005 provided statistically significant pain relief in patients undergoing bunionectomy, with results indicating a reduction in pain ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06017999

Study Details | NCT06017999 | XG005 for Pain Control in ...

This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects ...

4.

firstwordpharma.com

firstwordpharma.com/story/5924617

A Novel Non-Opioid Multimodal Analgesic from Xgene ...

Treatment with XG005 resulted in statistically significant and clinically meaningful reduction in post-surgical pain following bunionectomy ...

5.

drugtopics.com

drugtopics.com/view/non-opioid-analgesic-shown-to-reduce-post-surgical-pain-in-phase-2-trial

Non-Opioid Analgesic Shown to Reduce Post-Surgical ...

The study showed there was a statistically significant difference in summed pain intensity over 48 hours after surgery between XG005 and placebo ...

6.

painweek2025.eventscribe.net

painweek2025.eventscribe.net/ajaxcalls/PresentationInfo.asp?efp=UEFTRVdOUE0yNTUzNQ&PresentationID=1668924&rnd=0.4140327

a randomized, placebo-controlled phase 2b trial

XG005 as a non-opioid analgesic dose-dependently reduced acute post-operative pain with a large effect size, dramatically cut down opioid consumption and spared ...