At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 enrolled
Drug / intervention
XG005 tablet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy
In Brief
A Phase 3 clinical trial evaluating XG005 tablet and Placebo tablet for Acute Pain. Completed, enrolled 450 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
Enrollment StartAug 2023
First PostedAug 2023
Primary CompletionAug 2024
Study CompletionSep 2024
TodayJul 2026
First PostedAug 30, 2023
Enrollment StartAug 29, 2023
Primary CompletionAug 29, 2024
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 2.8 years ago
Interventions
XG005 tabletdrug
Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours.
Placebo tabletdrug
Subjects will receive placebo prior to surgery and every 12 hours for 72 hours.