Trial Outcomes & Findings for HTX-011 for Post-bunionectomy Analgesia (NCT NCT02471898)
NCT ID: NCT02471898
Last Updated: 2026-07-17
Results Overview
Summed Pain Intensity (SPI) Scores over the first 24 hours, which was the sum of the pain intensity scores at the scheduled 1 hour assessment, the assessments scheduled for every 2 hours between Hours 2 and 14, and the assessments scheduled at Hours 18 and 24; with the assessments at Hours 1 and 2 each weighted by 1, the assessments between Hours 4 and 14 each weighted by 2, the assessment at Hour 18 weighted by 4, and the assessment at Hour 24 weighted by 6. Pain was assessed using an 11-point scale, where 0 equaled no pain and 10 equaled the worst pain imaginable. Thus, the minimum and maximum possible SPI0-24 scores were 0 and 240, respectively.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
24 hours
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
Treatment Group 1
HTX-011 200 mg (3.42 mL)
|
Treatment Group 2
HTX-011 400 mg (6.84 mL)
|
Treatment Group 3
HTX-011 200 mg (6.84 mL)
|
Treatment Group 4
Saline Placebo (3.42 or 6.84 mL)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
5
|
24
|
|
Overall Study
COMPLETED
|
19
|
22
|
5
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group 1
HTX-011 200 mg (3.42 mL)
|
Treatment Group 2
HTX-011 400 mg (6.84 mL)
|
Treatment Group 3
HTX-011 200 mg (6.84 mL)
|
Treatment Group 4
Saline Placebo (3.42 or 6.84 mL)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
HTX-011 for Post-bunionectomy Analgesia
Baseline characteristics by cohort
| Measure |
Treatment Group 1
n=20 Participants
HTX-011A 200 mg (3.42 mL)
|
Treatment Group 2
n=22 Participants
HTX-011A 400 mg (6.84 mL)
|
Treatment Group 3
n=5 Participants
HTX-011B 200 mg (3.42 mL)
|
Treatment Group 4
n=24 Participants
Saline Placebo (3.42 or 6.84 mL)
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 10.9 • n=20 Participants
|
46.9 years
STANDARD_DEVIATION 13.6 • n=20 Participants
|
44.8 years
STANDARD_DEVIATION 10.6 • n=40 Participants
|
45.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 12.2 • n=9 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
22 participants
n=20 Participants
|
5 participants
n=40 Participants
|
24 participants
n=5 Participants
|
71 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Modified Intent-to-treat (MITT) Population
Summed Pain Intensity (SPI) Scores over the first 24 hours, which was the sum of the pain intensity scores at the scheduled 1 hour assessment, the assessments scheduled for every 2 hours between Hours 2 and 14, and the assessments scheduled at Hours 18 and 24; with the assessments at Hours 1 and 2 each weighted by 1, the assessments between Hours 4 and 14 each weighted by 2, the assessment at Hour 18 weighted by 4, and the assessment at Hour 24 weighted by 6. Pain was assessed using an 11-point scale, where 0 equaled no pain and 10 equaled the worst pain imaginable. Thus, the minimum and maximum possible SPI0-24 scores were 0 and 240, respectively.
Outcome measures
| Measure |
Treatment Group 1
n=20 Participants
HTX-011A 200 mg (3.42 mL)
|
Treatment Group 2
n=22 Participants
HTX-011A 400 mg (6.84 mL)
|
Treatment Group 3
n=5 Participants
HTX-011B 200 mg (3.42 mL)
|
Treatment Group 4
n=24 Participants
Saline Placebo (3.42 or 6.84 mL)
|
|---|---|---|---|---|
|
SPI0-24
|
106.6 Score on a scale
Standard Deviation 49.73
|
43.4 Score on a scale
Standard Deviation 49.68
|
73.2 Score on a scale
Standard Deviation 51.00
|
140.7 Score on a scale
Standard Deviation 43.95
|
Adverse Events
Treatment Group 1
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment Group 2
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Treatment Group 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Group 4
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group 1
n=20 participants at risk
HTX-011A 200 mg (3.42 mL)
|
Treatment Group 2
n=22 participants at risk
HTX-011A 400 mg (6.84 mL)
|
Treatment Group 3
n=5 participants at risk
HTX-011B 200 mg (3.42 mL)
|
Treatment Group 4
n=24 participants at risk
Saline Placebo (3.42 or 6.84 mL)
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Necrosis
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
Other adverse events
| Measure |
Treatment Group 1
n=20 participants at risk
HTX-011A 200 mg (3.42 mL)
|
Treatment Group 2
n=22 participants at risk
HTX-011A 400 mg (6.84 mL)
|
Treatment Group 3
n=5 participants at risk
HTX-011B 200 mg (3.42 mL)
|
Treatment Group 4
n=24 participants at risk
Saline Placebo (3.42 or 6.84 mL)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injection site haemorrhage
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Wound complication
|
10.0%
2/20 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
Investigations
Body temperature increased
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20
|
0.00%
0/22
|
20.0%
1/5 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
18.2%
4/22 • Number of events 4
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2
|
22.7%
5/22 • Number of events 5
|
20.0%
1/5 • Number of events 1
|
16.7%
4/24 • Number of events 4
|
|
Nervous system disorders
Syncope
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
16.7%
4/24 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/5
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
0.00%
0/20
|
0.00%
0/22
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Flushing
|
0.00%
0/20
|
0.00%
0/22
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Hot flush
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
General disorders
Necrosis
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
General disorders
Peripheral swelling
|
5.0%
1/20 • Number of events 1
|
0.00%
0/22
|
0.00%
0/5
|
0.00%
0/24
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Infections and infestations
Cellulitis
|
10.0%
2/20 • Number of events 2
|
18.2%
4/22 • Number of events 4
|
60.0%
3/5 • Number of events 3
|
0.00%
0/24
|
|
Infections and infestations
Fungal infection
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Blister
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Injection site erythema
|
0.00%
0/20
|
13.6%
3/22 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Injection site extravasation
|
5.0%
1/20 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20
|
0.00%
0/22
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3
|
13.6%
3/22 • Number of events 3
|
0.00%
0/5
|
16.7%
4/24 • Number of events 4
|
|
General disorders
Chills
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
General disorders
Fatigue
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
0.00%
0/5
|
0.00%
0/24
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Number of events 6
|
31.8%
7/22 • Number of events 7
|
20.0%
1/5 • Number of events 1
|
33.3%
8/24 • Number of events 8
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/20
|
4.5%
1/22 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place