Trial Outcomes & Findings for A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery (NCT NCT00818363)
NCT ID: NCT00818363
Last Updated: 2021-06-01
Results Overview
Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
0 to 72 hours post-dose
Results posted on
2021-06-01
Participant Flow
Participant milestones
| Measure |
Group 1: SABER-Bupivacaine
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
40
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Baseline characteristics by cohort
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
BMI
|
26.57 kg/m^2
STANDARD_DEVIATION 4.17 • n=5 Participants
|
29.33 kg/m^2
STANDARD_DEVIATION 5.08 • n=7 Participants
|
27.49 kg/m^2
STANDARD_DEVIATION 4.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 72 hours post-doseMean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
|
5.35 score on a scale
Standard Deviation 1.91
|
5.81 score on a scale
Standard Deviation 2.25
|
PRIMARY outcome
Timeframe: 0 to 72 hours post-doseMean total morphine-equivalent dose during the period 0 to 72 hours post-dose
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Supplemental Opioid Use
|
44.54 mg
Standard Deviation 29.62
|
49.94 mg
Standard Deviation 45.69
|
SECONDARY outcome
Timeframe: 0 to 72 hours post-doseFrequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention.
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Constipation
|
0 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Dizziness
|
14 Participants
|
6 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Drowsiness
|
20 Participants
|
12 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Nausea
|
17 Participants
|
11 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Respiratory Depression
|
3 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Urinary Retention
|
6 Participants
|
1 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 0 : Vomiting
|
12 Participants
|
4 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Constipation
|
5 Participants
|
1 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Dizziness
|
7 Participants
|
4 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Drowsiness
|
18 Participants
|
7 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Nausea
|
10 Participants
|
5 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Respiratory Depression
|
0 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Urinary Retention
|
3 Participants
|
2 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 1 : Vomiting
|
3 Participants
|
2 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Constipation
|
10 Participants
|
5 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Dizziness
|
4 Participants
|
3 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Drowsiness
|
13 Participants
|
8 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Nausea
|
8 Participants
|
2 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Respiratory Depression
|
0 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Urinary Retention
|
1 Participants
|
1 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 2 : Vomiting
|
1 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Constipation
|
9 Participants
|
4 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Dizziness
|
1 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Drowsiness
|
10 Participants
|
2 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Nausea
|
4 Participants
|
1 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Respiratory Depression
|
0 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Urinary Retention
|
1 Participants
|
0 Participants
|
|
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Day 3 : Vomiting
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 48 hours post-doseMean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).
|
5.65 score on a scale
Standard Deviation 2.07
|
6.14 score on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: 0 to 48 hours post-doseMean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Supplemental Opioid Use
|
37.13 mg
Standard Deviation 23.40
|
43.70 mg
Standard Deviation 37.44
|
SECONDARY outcome
Timeframe: 0 to 14 days post-doseOutcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=40 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 Participants
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Time-to-first Use of Opioid Supplemental Pain Medication
|
0.43 hours
Interval 0.37 to 0.58
|
0.48 hours
Interval 0.28 to 0.68
|
SECONDARY outcome
Timeframe: 0 to 14 days post-dosePopulation: Severity of opioid related side effects were not collected in the opioid related side effects diary.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: SABER-Bupivacaine
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Group 2: SABER-Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: SABER-Bupivacaine
n=40 participants at risk
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 participants at risk
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
General disorders
Pyrexia
|
2.5%
1/40
|
0.00%
0/20
|
Other adverse events
| Measure |
Group 1: SABER-Bupivacaine
n=40 participants at risk
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
|
Group 2: SABER-Placebo
n=20 participants at risk
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
15.0%
6/40
|
5.0%
1/20
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40
|
5.0%
1/20
|
|
Gastrointestinal disorders
Constipation
|
45.0%
18/40
|
50.0%
10/20
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40
|
5.0%
1/20
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
4/40
|
10.0%
2/20
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/40
|
5.0%
1/20
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/40
|
5.0%
1/20
|
|
Gastrointestinal disorders
Nausea
|
65.0%
26/40
|
75.0%
15/20
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
14/40
|
20.0%
4/20
|
|
General disorders
Oedema Peripheral
|
5.0%
2/40
|
0.00%
0/20
|
|
General disorders
Pyrexia
|
10.0%
4/40
|
5.0%
1/20
|
|
General disorders
Sensation Of Pressure
|
0.00%
0/40
|
5.0%
1/20
|
|
Infections and infestations
Rhinitis
|
0.00%
0/40
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Post Procedural Swelling
|
0.00%
0/40
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.5%
1/40
|
5.0%
1/20
|
|
Investigations
Blood Pressure Increased
|
2.5%
1/40
|
5.0%
1/20
|
|
Investigations
Respiratory Rate Decreased
|
0.00%
0/40
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/40
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/40
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
7.5%
3/40
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
35.0%
14/40
|
35.0%
7/20
|
|
Nervous system disorders
Dysgeusia
|
12.5%
5/40
|
5.0%
1/20
|
|
Nervous system disorders
Headache
|
12.5%
5/40
|
20.0%
4/20
|
|
Nervous system disorders
Hypoaesthesia
|
17.5%
7/40
|
15.0%
3/20
|
|
Nervous system disorders
Paraesthesia
|
22.5%
9/40
|
10.0%
2/20
|
|
Nervous system disorders
Somnolence
|
72.5%
29/40
|
80.0%
16/20
|
|
Renal and urinary disorders
Dysuria
|
20.0%
8/40
|
20.0%
4/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.5%
3/40
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
2/40
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
7.5%
3/40
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
8/40
|
10.0%
2/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place