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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose | Experimental | XG005 1250 mg Q12 hours |
|
| low dose | Experimental | XG005 750 mg Q12 hours |
|
| placebo | Placebo Comparator | placebo Q12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XG005 tablet | Drug | Subjects will receive XG005 prior to surgery and every 12 hours for 72 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main inclusion criteria:
Main exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Pacific Research Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41737923 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High dose | XG005 1250 mg Q12 hours |
| FG001 | Low dose | XG005 750 mg Q12 hours |
| FG002 | Placebo | Placebo Q12 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population was defined as all randomized subjects (Intend-To-Treat population).
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | XG005 1250 mg Q12 hours |
| BG001 | Low Dose | XG005 750 mg Q12 hours |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The number of participants met the protocol requirement regarding the participants to be male or female, aged 18-80 years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | Numeric score | 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 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High dose | XG005 1250 mg Q12 hours | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Xgene Pharmaceutical | +886-2-2528-0580 | emily.chen@xgenepharm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | Aug 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo tablet | Drug | Subjects will receive placebo prior to surgery and every 12 hours for 72 hours. |
|
| 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. |
| San Diego |
| California |
| 92128 |
| United States |
| Clinical Pharmacology of Miami | Hialeah | Florida | 33014 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | 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 |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Non-Compliance |
|
| Lack of Efficacy |
|
| COVID Positive |
|
| Did Not Disclose Amount of EtOH Consumed |
|
| Placebo |
Placebo Q12 hours |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The number of participants from various ethnic backgrounds. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The number of participants from various races. | Count of Participants | Participants |
|
| Region of Enrollment | The number of participants from the US. | Count of Participants | Participants |
|
| Body Mass Index | Body Mass Index (BMI) was assessed as part of eligibility screening. Participants were required to have a body weight greater than 50 kg and a BMI less than 39 kg/m² to meet the inclusion criteria. BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²). | Three participants in the Placebo group had their BMI data not captured. | Mean | Standard Deviation | kg/m^2 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | High dose | XG005 1250 mg Q12 hours |
| OG001 | Placebo | Placebo Q12 hours |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Numeric score | 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. |
|
|
|
|
| 152 |
| 0 |
| 152 |
| 88 |
| 152 |
| EG001 | Low dose | XG005 750 mg Q12 hours | 0 | 149 | 0 | 149 | 69 | 149 |
| EG002 | Placebo | Placebo Q12 hours | 0 | 147 | 0 | 147 | 62 | 147 |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
Upon study completion, the sponsor decides data reporting, publication venue, and authorship. Data remain the sponsor's property and require sponsor approval for publication, which will not be unreasonably withheld.
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|