Clinical trial NCT06017999: XG005 for Pain Control in Subjects Undergoing Bunionectomy
Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Pain
Lead sponsor: Xgene Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

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.

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

Primary outcomes:
measure: Summed pain intensity from end of surgery to 48 hours post-surgery
timeFrame: 0 to 72 hours post-surgery
Secondary outcomes:
measure: Total tramadol rescue medication consumption
timeFrame: 0 to 72 hours post-surgery
measure: Total tramadol rescue medication consumption
timeFrame: 0 to 72 hours post-surgery
measure: Time to first use of rescue medication from end of surgery
timeFrame: 0 to 72 hours post-surgery
measure: Time to first use of rescue medication from end of surgery
timeFrame: 0 to 72 hours post-surgery
measure: Patient Global Assessment (PGA) at 48 hours
timeFrame: 0 to 72 hours post-surgery
measure: Patient Global Assessment (PGA) at 48 hours
timeFrame: 0 to 72 hours post-surgery
measure: Total acetaminophen rescue medication consumption
timeFrame: 0 to 72 hours post-surgery
measure: Total acetaminophen rescue medication consumption
timeFrame: 0 to 72 hours post-surgery
measure: Summed pain intensity from end of surgery to 48 hours post-surgery (SPI48)
timeFrame: 0 to 72 hours post-surgery
measure: Summed pain intensity from end of surgery to 48 hours post-surgery (SPI48)
timeFrame: 0 to 72 hours post-surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Hialeah
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: Legent Orthopedic Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Village
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
Study officials:
References: