XG005 for Pain Control in Subjects Undergoing Bunionectomy

Purpose

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.

Condition

  • Acute Pain

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Memorial Hermann Village
Houston, Texas 77043

More Details

Status
Recruiting
Sponsor
Xgene Pharmaceutical Group

Study Contact

Joey Chang
312-468-5090
joey.chang@xgenepharm.com

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.