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Completed

NCT Number: NCT06017999

XG005 for Pain Control 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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Arizona Research Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XG005 tablet

Drug

Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.

Placebo Tablet

Drug

Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.

Primary outcomes

  1. 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.

    Time frame: 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.

    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.

Secondary outcomes

  1. 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.

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Xgene Pharmaceutical Group

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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