XG005 for Post-Bunionectomy Pain
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.12345Why 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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 750 mg XG005, 1250 mg XG005, or placebo twice a day post-surgery for 72 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- XG005
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xgene Pharmaceutical Group
Lead Sponsor