XG005 for Pain Control in Subjects Undergoing Bunionectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Summed pain intensity from end of surgery to 48 hours post-surgery [0 to 72 hours post-surgery]
Pain assessments via a standard 11-point NPRS at the various time points post-end of surgery
Secondary Outcome Measures
- Total tramadol rescue medication consumption [0 to 72 hours post-surgery]
Tramadol 50 mg, PRN
- Time to first use of rescue medication from end of surgery [0 to 72 hours post-surgery]
Acetaminophen 1g, PRN
- Patient Global Assessment (PGA) at 48 hours [0 to 72 hours post-surgery]
PGA of pain control using a 5 point scale at the following time points post-surgery
- Cumulative Nausea (NNRS) assessment scores through 24 hours [0 to 72 hours post-surgery]
NNRS assessment scores at various time points
- TEAEs [Day 1 to Day 30]
First dose of study drug to 30 days after the last dose of study drug
- Continuous Pulse Oximetry [0 to 72 hours post-surgery]
oxygen saturation (Sp02) will be recorded every 12 hours post-end of surgery.
Eligibility Criteria
Criteria
Main inclusion criteria:
-
Scheduled to undergo unilateral first metatarsal bunionectomy
-
Have negative urine drug screen
-
Non-pregnant, non-lactating
Main exclusion criteria:
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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
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Digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics
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Monoamine oxidase inhibitors (MAOIs)
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
| 2 | First Surgical Hospital | Bellaire | Texas | United States | 77401 |
| 3 | Legent Orthopedic Hospital | Carrollton | Texas | United States | 75006 |
| 4 | Memorial Hermann Village | Houston | Texas | United States | 77043 |
| 5 | Endeavor Clinical Trials | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Xgene Pharmaceutical Group
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PR-XG005-02-BUN-01