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New pain pill shows promise for Post-Surgery relief

NCT ID NCT06017999

Symptom relief Sponsor: Xgene Pharmaceutical Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an experimental painkiller called XG005 can safely reduce pain after bunion surgery. About 450 adults took either a low dose, high dose, or a placebo pill. Researchers measured pain levels over 48 hours using a simple 0-to-10 pain scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

450 people

The number who actually took part.

Started

Aug 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Acute Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pain

Contacts and locations

Locations

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • Clinical Pharmacology of Miami

    Hialeah, Florida, 33014, United States

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229, United States

  • First Surgical Hospital

    Bellaire, Texas, 77401, United States

  • Legent Orthopedic Hospital

    Carrollton, Texas, 75006, United States

  • Memorial Hermann Village

    Houston, Texas, 77043, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • Pacific Research Network

    San Diego, California, 92128, United States

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