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: Recruiting
• 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 (Estimated): 450
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Joey Chang; Phone Number: 312-468-5090; Email: joey.chang@xgenepharm.com

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Recruiting
      • Midwest Clinical Research Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • First Surgical Hospital
    • Carrollton, Texas, United States, 75006
      • Recruiting
      • Legent Orthopedic Hospital
    • Houston, Texas, United States, 77043
      • Recruiting
      • Memorial Hermann Village
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • 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
Summed pain intensity from end of surgery to 48 hours post-surgery	Pain assessments via a standard 11-point NPRS at the various time points post-end of surgery	0 to 72 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total tramadol rescue medication consumption	Tramadol 50 mg, PRN	0 to 72 hours post-surgery
Time to first use of rescue medication from end of surgery	Acetaminophen 1g, PRN	0 to 72 hours post-surgery
Patient Global Assessment (PGA) at 48 hours	PGA of pain control using a 5 point scale at the following time points post-surgery	0 to 72 hours post-surgery
Cumulative Nausea (NNRS) assessment scores through 24 hours	NNRS assessment scores at various time points	0 to 72 hours post-surgery
TEAEs	First dose of study drug to 30 days after the last dose of study drug	Day 1 to Day 30
Continuous Pulse Oximetry	oxygen saturation (Sp02) will be recorded every 12 hours post-end of surgery.	0 to 72 hours post-surgery

Collaborators and Investigators

• Sponsor: Xgene Pharmaceutical Group

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 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): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; 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