XG005 for Pain Control in Subjects Undergoing Bunionectomy

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: XG005 tablet; Drug: Placebo tablet

• Registration Number: NCT06017999
• Lead Sponsor: Xgene Pharmaceutical Group

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-24
• Study Start: 2023-08-29
• Study First Posted: 2023-08-30
• Primary Completion: 2024-08-29
• Study Completion: 2024-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose	XG005 tablet	XG005 1250 mg Q12 hours
low dose	XG005 tablet	XG005 750 mg Q12 hours
low dose	Placebo tablet	XG005 750 mg Q12 hours
placebo	Placebo tablet	placebo Q12 hours

Primary Outcome Measures

Name	Time	Method
Summed pain intensity from end of surgery to 48 hours post-surgery	0 to 72 hours post-surgery	Pain assessments via a standard 11-point NPRS at the various time points post-end of surgery

Secondary Outcome Measures

Name	Time	Method
Total tramadol rescue medication consumption	0 to 72 hours post-surgery	Low dose XG005 versus placebo
Time to first use of rescue medication from end of surgery	0 to 72 hours post-surgery	Low dose XG005 versus placebo
Patient Global Assessment (PGA) at 48 hours	0 to 72 hours post-surgery	Low dose XG005 versus placebo
Total acetaminophen rescue medication consumption	0 to 72 hours post-surgery	Low dose XG005 versus placebo
Summed pain intensity from end of surgery to 48 hours post-surgery (SPI48)	0 to 72 hours post-surgery	High dose XG005 versus low dose XG005

Trial Locations

Locations (8)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States

Clinical Pharmacology of Miami; 🇺🇸 Hialeah, Florida, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

First Surgical Hospital; 🇺🇸 Bellaire, Texas, United States

Legent Orthopedic Hospital; 🇺🇸 Carrollton, Texas, United States

Memorial Hermann Village; 🇺🇸 Houston, Texas, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States