XG005 for Pain Control in Subjects Undergoing Bunionectomy

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017999
• Other study ID #: PR-XG005-02-BUN-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 8, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2023
• Source: Xgene Pharmaceutical Group
• Contact: Joey Chang
• Phone: 312-468-5090
• Email: joey.chang[@]xgenepharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• XG005 tablet
Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.
• Placebo tablet
Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.

Locations

Country	Name	City	State
United States	First Surgical Hospital	Bellaire	Texas
United States	Legent Orthopedic Hospital	Carrollton	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Memorial Hermann Village	Houston	Texas
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xgene Pharmaceutical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total tramadol rescue medication consumption	Tramadol 50 mg, PRN	0 to 72 hours post-surgery
Secondary	Time to first use of rescue medication from end of surgery	Acetaminophen 1g, PRN	0 to 72 hours post-surgery
Secondary	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
Secondary	Cumulative Nausea (NNRS) assessment scores through 24 hours	NNRS assessment scores at various time points	0 to 72 hours post-surgery
Secondary	TEAEs	First dose of study drug to 30 days after the last dose of study drug	Day 1 to Day 30
Secondary	Continuous Pulse Oximetry	oxygen saturation (Sp02) will be recorded every 12 hours post-end of surgery.	0 to 72 hours post-surgery