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XG005 for Pain Control in Subjects Undergoing Bunionectomy

NCT06017999 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-11-17

Study results available
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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.

Conditions

  • Acute Pain

Interventions

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.

Sponsors & Collaborators

  • Xgene Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2024-08-29
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06017999 on ClinicalTrials.gov