Acute PainPhase 2/3NCT06017999

XG005 for Pain Control in Subjects Undergoing Bunionectomy

A Phase 2/3 study testing XG005 tablet in people with Acute Pain, run by Xgene Pharmaceutical Group at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Pain
What is being tested?: XG005 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 450 participants
Where: 8 sitesUnited States
Study dates: 29 Aug 2023to 30 Sep 2024
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

First Surgical Hospital
Bellaire, Texas, 77401
Legent Orthopedic Hospital
Carrollton, Texas, 75006
Midwest Clinical Research Center
Dayton, Ohio, 45417
Clinical Pharmacology of Miami
Hialeah, Florida, 33014
Memorial Hermann Village
Houston, Texas, 77043
Arizona Research Center
Phoenix, Arizona, 85053
Endeavor Clinical Trials
San Antonio, Texas, 78229
Pacific Research Network
San Diego, California, 92128

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy

Read the 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.

Conditions: Acute Pain
Being tested: XG005 tablet, Placebo tablet
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06017999
Study group	Role	What they receive
high dose	Experimental	XG005 1250 mg Q12 hours Receives: Drug: XG005 tablet
low dose	Experimental	XG005 750 mg Q12 hours Receives: Drug: XG005 tablet; Drug: Placebo tablet
placebo	Placebo comparator	placebo Q12 hours Receives: Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
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.
Measured: 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.

Secondary outcomes (1)

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.
The secondary efficacy endpoint 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.
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.
The pairwise treatment comparison 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 low-dose versus placebo comparison, SPI48 ranged from 0 to 383 in the low-dose group and from 0 to 446 in the placebo group.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 202330 Sep 2024

First posted30 Aug 2023
Study start29 Aug 2023
Primary completion29 Aug 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06017999
Sponsor's protocol ID: PR-XG005-02-BUN-01
Status last verified: Sep 2025
First submitted: 18 Aug 2023
Last updated: 17 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Jiang GL, Evanson JR, Solanki D, D'Aunno D, DeNoia E, Rondon JC, Beaton A, Taber L. Pregabalin naproxencarbil in acute post-bunionectomy pain: a randomized clinical trial. Pain Rep. 2026 Jan 20;11(2):e1424. doi: 10.1097/PR9.0000000000001424. eCollection 2026 Apr.
PubMed 41737923

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of XG005 Tablets in Subjects Undergoing Bunionectomy
ClinicalTrials.gov ID: NCT06017999
Acronym / sponsor ID: PR-XG005-02-BUN-01
Conditions: Acute Pain
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Xgene Pharmaceutical GroupIndustry (pharma, biotech, devices)
Study start: 29 Aug 2023 (actual)
Primary completion: 29 Aug 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 30 Aug 2023 (actual)
Results: Posted 17 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
high dose	Experimental	Drug: XG005 tabletXG005 1250 mg Q12 hours
low dose	Experimental	Drug: XG005 tablet, Drug: Placebo tabletXG005 750 mg Q12 hours
placebo	Placebo comparator	Drug: Placebo tabletplacebo Q12 hours

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XG005 tabletSubjects will receive XG005 prior to surgery and every 12 hours for 72 hours.	Drug	high dose, low dose
Placebo tabletSubjects will receive placebo prior to surgery and every 12 hours for 72 hours.	Drug	low dose, placebo

Primary outcome

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.

1 secondary outcome

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.
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.

Results and safety

Results posted to the registry on 17 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High dose	152	148
Low dose	149	142
Placebo	149	135

Primary outcome: 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.. Least squares mean (Standard Error). Unit: Numeric score

Measure	High dose n = 152	Placebo n = 149
Value	132.63 (8.004)	285.99 (8.183)

High dose vs Placebo: Least Square Mean (LSM) difference: -153.35 (95% CI -173.80 to -132.91), p <0.0001, ANCOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The AE reporting period began at the time of the first dose of the study drug and ended 30 days after the last dose of the study drug, up to five weeks. AEs starting after the administration of the first dose of the study medications were considered to be TEAEs. All AEs were followed until they were resolved, stable, or deemed by the investigator to be not clinically significant, over a maximum period of five weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High dose	0 of 152 (0%)	88 of 152 (57.9%)	0 of 152
Low dose	0 of 149 (0%)	69 of 149 (46.3%)	0 of 149
Placebo	0 of 147 (0%)	62 of 147 (42.2%)	0 of 147

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41737923Jiang GL, Evanson JR, Solanki D, D'Aunno D, DeNoia E, Rondon JC, Beaton A, Taber L. Pregabalin naproxencarbil in acute post-bunionectomy pain: a randomized clinical trial. Pain Rep. 2026 Jan 20;11(2):e1424. doi: 10.1097/PR9.0000000000001424. eCollection 2026 Apr.

Related trials for Acute Pain

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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing XG005 tablet in people with Acute Pain, run by Xgene Pharmaceutical Group at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017999, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.