Trial Outcomes & Findings for XG005 for Pain Control in Subjects Undergoing Bunionectomy (NCT NCT06017999)

Last Updated: 2025-11-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

450 participants

Primary outcome timeframe

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 posted on

2025-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	High dose XG005 1250 mg Q12 hours	Low dose XG005 750 mg Q12 hours	Placebo Placebo Q12 hours
Overall Study STARTED	152	149	149
Overall Study Safety set	152	149	147
Overall Study COMPLETED	148	142	135
Overall Study NOT COMPLETED	4	7	14

Reasons for withdrawal

Reasons for withdrawal
Measure	High dose XG005 1250 mg Q12 hours	Low dose XG005 750 mg Q12 hours	Placebo Placebo Q12 hours
Overall Study Withdrawal by Subject	0	4	3
Overall Study Adverse Event	2	1	1
Overall Study Lost to Follow-up	0	0	1
Overall Study Physician Decision	1	1	0
Overall Study Non-Compliance	0	0	1
Overall Study Lack of Efficacy	1	0	7
Overall Study COVID Positive	0	1	0
Overall Study Did Not Disclose Amount of EtOH Consumed	0	0	1

Baseline Characteristics

Three participants in the Placebo group had their BMI data not captured.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose n=152 Participants XG005 1250 mg Q12 hours	Low Dose n=149 Participants XG005 750 mg Q12 hours	Placebo n=149 Participants Placebo Q12 hours	Total n=450 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=152 Participants	1 Participants n=149 Participants	1 Participants n=149 Participants	3 Participants n=450 Participants
Age, Categorical Between 18 and 65 years	146 Participants n=152 Participants	140 Participants n=149 Participants	137 Participants n=149 Participants	423 Participants n=450 Participants
Age, Categorical >=65 years	5 Participants n=152 Participants	8 Participants n=149 Participants	11 Participants n=149 Participants	24 Participants n=450 Participants
Sex: Female, Male Female	123 Participants n=152 Participants	117 Participants n=149 Participants	120 Participants n=149 Participants	360 Participants n=450 Participants
Sex: Female, Male Male	29 Participants n=152 Participants	32 Participants n=149 Participants	29 Participants n=149 Participants	90 Participants n=450 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	57 Participants n=152 Participants	50 Participants n=149 Participants	57 Participants n=149 Participants	164 Participants n=450 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=152 Participants	97 Participants n=149 Participants	91 Participants n=149 Participants	283 Participants n=450 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=152 Participants	2 Participants n=149 Participants	1 Participants n=149 Participants	3 Participants n=450 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=152 Participants	1 Participants n=149 Participants	0 Participants n=149 Participants	1 Participants n=450 Participants
Race (NIH/OMB) Asian	5 Participants n=152 Participants	2 Participants n=149 Participants	1 Participants n=149 Participants	8 Participants n=450 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=152 Participants	1 Participants n=149 Participants	0 Participants n=149 Participants	1 Participants n=450 Participants
Race (NIH/OMB) Black or African American	40 Participants n=152 Participants	55 Participants n=149 Participants	49 Participants n=149 Participants	144 Participants n=450 Participants
Race (NIH/OMB) White	103 Participants n=152 Participants	82 Participants n=149 Participants	94 Participants n=149 Participants	279 Participants n=450 Participants
Race (NIH/OMB) More than one race	2 Participants n=152 Participants	1 Participants n=149 Participants	0 Participants n=149 Participants	3 Participants n=450 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=152 Participants	7 Participants n=149 Participants	5 Participants n=149 Participants	14 Participants n=450 Participants
Region of Enrollment United States	152 Participants n=152 Participants	149 Participants n=149 Participants	149 Participants n=149 Participants	450 Participants n=450 Participants
Body Mass Index	28.37 kg/m^2 STANDARD_DEVIATION 4.370 • n=152 Participants • Three participants in the Placebo group had their BMI data not captured.	28.52 kg/m^2 STANDARD_DEVIATION 4.464 • n=149 Participants • Three participants in the Placebo group had their BMI data not captured.	28.05 kg/m^2 STANDARD_DEVIATION 4.764 • n=146 Participants • Three participants in the Placebo group had their BMI data not captured.	28.32 kg/m^2 STANDARD_DEVIATION 4.527 • n=447 Participants • Three participants in the Placebo group had their BMI data not captured.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High dose n=152 Participants XG005 1250 mg Q12 hours	Placebo n=149 Participants Placebo Q12 hours
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.	132.63 Numeric score Standard Error 8.004	285.99 Numeric score Standard Error 8.183

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	High dose n=149 Participants XG005 1250 mg Q12 hours	Placebo n=149 Participants Placebo Q12 hours
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.	157.86 Numeric score Standard Error 8.345	289.50 Numeric score Standard Error 8.500

Adverse Events

High dose

Serious events: 0 serious events

Other events: 88 other events

Deaths: 0 deaths

Low dose

Serious events: 0 serious events

Other events: 69 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High dose n=152 participants at risk XG005 1250 mg Q12 hours	Low dose n=149 participants at risk XG005 750 mg Q12 hours	Placebo n=147 participants at risk Placebo Q12 hours
Nervous system disorders Somnolence	15.1% 23/152 • Number of events 25 • 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.	10.7% 16/149 • Number of events 16 • 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.	0.00% 0/147 • 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.
Nervous system disorders Dizziness	13.8% 21/152 • Number of events 22 • 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.	11.4% 17/149 • Number of events 19 • 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.	4.1% 6/147 • Number of events 7 • 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.
Gastrointestinal disorders Nausea	15.8% 24/152 • Number of events 27 • 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.	10.7% 16/149 • Number of events 18 • 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.	12.9% 19/147 • Number of events 19 • 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.
Gastrointestinal disorders Constipation	11.8% 18/152 • Number of events 18 • 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.	8.7% 13/149 • Number of events 13 • 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.	4.8% 7/147 • Number of events 7 • 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.
Gastrointestinal disorders Vomitting	5.9% 9/152 • Number of events 11 • 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.	3.4% 5/149 • Number of events 6 • 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.	4.1% 6/147 • Number of events 6 • 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.
Nervous system disorders Headache	4.6% 7/152 • Number of events 7 • 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.	5.4% 8/149 • Number of events 9 • 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.	8.2% 12/147 • Number of events 15 • 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.
Psychiatric disorders Anxiety	0.00% 0/152 • 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.	0.67% 1/149 • Number of events 1 • 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.	2.0% 3/147 • Number of events 3 • 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.
Skin and subcutaneous tissue disorders Rash	0.66% 1/152 • Number of events 1 • 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.	0.00% 0/149 • 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.	2.7% 4/147 • Number of events 4 • 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.
Injury, poisoning and procedural complications Fall	2.0% 3/152 • Number of events 3 • 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.	2.0% 3/149 • Number of events 4 • 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.	0.00% 0/147 • 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.
Vascular disorders Hypertension	0.66% 1/152 • Number of events 1 • 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.	0.67% 1/149 • Number of events 1 • 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.	3.4% 5/147 • Number of events 5 • 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.
Eye disorders Vision blurred	3.3% 5/152 • Number of events 5 • 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.	2.0% 3/149 • Number of events 3 • 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.	0.00% 0/147 • 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.
Investigations Alanine aminotransferase increased	2.0% 3/152 • Number of events 3 • 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.	2.0% 3/149 • Number of events 3 • 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.	0.68% 1/147 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	0.00% 0/152 • 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.	2.0% 3/149 • Number of events 3 • 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.	0.00% 0/147 • 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.
Eye disorders Diplopia	2.6% 4/152 • Number of events 4 • 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.	0.67% 1/149 • Number of events 1 • 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.	0.00% 0/147 • 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.

Additional Information

Director of Clinical Trials

Xgene Pharmaceutical

Phone: +886-2-2528-0580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER