A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 450
- Locations
- 8
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
high dose
XG005 1250 mg Q12 hours
Intervention: XG005 tablet (Drug)
low dose
XG005 750 mg Q12 hours
Intervention: XG005 tablet (Drug)
low dose
XG005 750 mg Q12 hours
Intervention: Placebo tablet (Drug)
placebo
placebo Q12 hours
Intervention: Placebo tablet (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: SPI NPRS collection times occurred at 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours, within a ±10-minute window.
The primary efficacy endpoint 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. Subject-reported pain assessments via a standard 11-point Numeric Pain Rating Scale (NPRS, a scale of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). 0 means "no pain",10 means "worst pain imaginable") at the following time points post-end of surgery: 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours within a ±10-minute window. Each pairwise treatment comparison (e.g., high dose vs. placebo, low dose vs. placebo) was analyzed using a separate ANCOVA model that included only the relevant treatment arms and adjusted for study site. As a result, the placebo least squares mean may differ slightly across comparisons due to differences in covariate adjustment. For the high-dose versus placebo comparison, SPI48 ranged from 0 to 425 in the high-dose group and from 0 to 446 in the placebo group.
Secondary Outcomes
- 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.(SPI NPRS collection times occurred at 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48 hours, within a ±10-minute window.)