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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: XG005 tablet; Drug: Placebo tablet

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 Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • California
    • San Diego, California, United States, 92128
      • Pacific Research Network
  • Florida
    • Hialeah, Florida, United States, 33014
      • Clinical Pharmacology of Miami
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • First Surgical Hospital
    • Carrollton, Texas, United States, 75006
      • Legent Orthopedic Hospital
    • Houston, Texas, United States, 77043
      • Memorial Hermann Village
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main inclusion criteria:

• Scheduled to undergo unilateral first metatarsal bunionectomy
• Have negative urine drug screen
• Non-pregnant, non-lactating

Main exclusion criteria:

• Medical condition or history that in the investigator's opinion could adversely impact the subject's participation or safety
• Use of disallowed medications (e.g. pain medication, CNS active drugs such as benzodiazepines, tricyclic antidepressants, Serotonin, and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), or any other serotonergic medications, parenteral or oral corticosteroids)
• Antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days
• Digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics
• Monoamine oxidase inhibitors (MAOIs)
• Positive HbsAg and/or anti-HBc but negative anti-HBs
• HIV infection
• History of illicit drug use
• History of opioid dependence
• History of NSAID-induced bronchospasm or presence of nasal polyps, history of asthma or chronic rhinitis
• Significant history of allergic reactions or known intolerance to naproxen, pregabalin or any gabapentinoid, or to any rescue medication used in the study, or any medication used in the surgical and anesthetic protocol.
• Presence of severe depression as indicated by Patient Health Questionnaire (PHQ 9) total score of ≥20 or item 9 score >0
• Presence of severe anxiety as indicated by General Anxiety Disorder (GAD-7) score of ≥15
• Presence of history of suicidal behavior or ideation as indicated by the C-SSRS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high dose; XG005 1250 mg Q12 hours	Drug: XG005 tablet; Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.
Experimental: low dose; XG005 750 mg Q12 hours	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.
Placebo Comparator: placebo; placebo Q12 hours	Drug: Placebo tablet; Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compared the Summed Pain Intensity From the End of Surgery to 48 Hours (SPI48) Between the High-dose XG005 Group and the Placebo Group Postoperatively.	The primary efficacy endpoint compared the Summed Pain Intensity from the End of Surgery to 48 Hours (SPI48) between the high-dose XG005 group and the placebo group postoperatively. Subject-reported pain assessments via a standard 11-point Numeric Pain Rating Scale (NPRS, a scale of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). 0 means "no pain",10 means "worst pain imaginable") at the following time points post-end of surgery: 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours within a ±10-minute window. Each pairwise treatment comparison (e.g., high dose vs. placebo, low dose vs. placebo) was analyzed using a separate ANCOVA model that included only the relevant treatment arms and adjusted for study site. As a result, the placebo least squares mean may differ slightly across comparisons due to differences in covariate adjustment. For the high-dose versus placebo comparison, SPI48 ranged from 0 to 425 in the high-dose group and from 0 to 446 in the placebo group.	SPI NPRS collection times occurred at 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours, within a ±10-minute window.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compared the Summed Pain Intensity From the End of Surgery to 48 Hours (SPI48) Between the Low-dose XG005 Group and the Placebo Group Postoperatively.	The secondary efficacy endpoint compared the Summed Pain Intensity from the End of Surgery to 48 Hours (SPI48) between the low-dose XG005 group and the placebo group postoperatively. Subject-reported pain assessments via a standard 11-point Numeric Pain Rating Scale (NPRS, a scale of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). 0 means "no pain",10 means "worst pain imaginable") at the following time points post-end of surgery: 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours within a ±10-minute window. The pairwise treatment comparison was analyzed using a separate ANCOVA model that included only the relevant treatment arms and adjusted for study site. As a result, the placebo least squares mean may differ slightly across comparisons due to differences in covariate adjustment. For the low-dose versus placebo comparison, SPI48 ranged from 0 to 383 in the low-dose group and from 0 to 446 in the placebo group.	SPI NPRS collection times occurred at 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours, within a ±10-minute window.

Collaborators and Investigators

• Sponsor: Xgene Pharmaceutical Group

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain
• Other Study ID Numbers: PR-XG005-02-BUN-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No