Status:
COMPLETED
XG005 for Pain Control in Subjects Undergoing Bunionectomy
Lead Sponsor:
Xgene Pharmaceutical Group
Conditions:
Acute Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 confin...
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 plac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06017999
Start Date
August 29 2023
End Date
September 30 2024
Last Update
November 17 2025
Active Locations (8)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Pacific Research Network
San Diego, California, United States, 92128
3
Clinical Pharmacology of Miami
Hialeah, Florida, United States, 33014
4
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417