XG005 for Pain Control in Subjects Undergoing Bunionectomy

NCT06017999 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PR-XG005-02-BUN-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Pain

Outcome Measures

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.

  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 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.

  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.

Study Arms (3)

high dose

EXPERIMENTAL

XG005 1250 mg Q12 hours

Drug: XG005 tablet

low dose

EXPERIMENTAL

XG005 750 mg Q12 hours

Drug: XG005 tablet; Drug: Placebo tablet

placebo

PLACEBO COMPARATOR

placebo Q12 hours

Drug: Placebo tablet

Interventions

XG005 tablet DRUG

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

high dose; low dose

Placebo tablet DRUG

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

low dose; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xgene Pharmaceutical Group: lead

Study Sites (8)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Pacific Research Network

San Diego, California, 92128, United States

Location

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Xgene Pharmaceutical

emily.chen@xgenepharm.com

+886-2-2528-0580

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 30, 2023
• Study Start: August 29, 2023
• Primary Completion: August 29, 2024
• Study Completion: September 30, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-09

Locations

US (8)