NCT06017999

XG005 for Pain Control in Subjects Undergoing Bunionectomy

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Xgene Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

Detailed description

This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg XG005, 1250 mg XG005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. Subjects and all study staff performing study assessments will be blinded to treatment allocation. Subjects will be discharged at a reasonable hour of the day after the end of the 72-hour treatment period.There will be a Follow-up Visit on Day 15.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	XG005 tablet	Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.
DRUG	Placebo tablet	Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.

Timeline

• Start date: 2023-08-29
• Primary completion: 2024-08-29
• Completion: 2024-09-30
• First posted: 2023-08-30
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study