The trial is taking place at:
H

HD Research LLC | First Surgical Hospital

Veeva-enabled site

XG005 for Pain Control in Subjects Undergoing Bunionectomy

X

Xgene Pharmaceutical

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Acute Pain

Treatments

Drug: XG005 tablet
Drug: Placebo tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT06017999
PR-XG005-02-BUN-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

450 participants in 3 patient groups, including a placebo group

high dose
Experimental group
Description:
XG005 1250 mg Q12 hours
Treatment:
Drug: XG005 tablet
low dose
Experimental group
Description:
XG005 750 mg Q12 hours
Treatment:
Drug: Placebo tablet
Drug: XG005 tablet
placebo
Placebo Comparator group
Description:
placebo Q12 hours
Treatment:
Drug: Placebo tablet

Trial contacts and locations

5

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Central trial contact

Joey Chang

Data sourced from clinicaltrials.gov

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