Phase 3
N=450
XG005 for Pain Control in Subjects Undergoing Bunionectomy
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT06017999 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Compared the Summed Pain Intensity From the End of Surgery to 48 Hours (SPI48) Between the High-dose XG005 Group and the Placebo Group Postoperatively. — 132.63; 285.99 Numeric score — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- XG005 tablet (Drug); Placebo tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xgene Pharmaceutical Group
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compared the Summed Pain Intensity From the End of Surgery to 48 Hours (SPI48) Between the High-dose XG005 Group and the Placebo Group Postoperatively. |
132.63; 285.99 | <0.0001 sig |
| SECONDARY Compared the Summed Pain Intensity From the End of Surgery to 48 Hours (SPI48) Between the Low-dose XG005 Group and the Placebo Group Postoperatively. |
157.86; 289.50 | <0.0001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT06017999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.