Trial Outcomes & Findings for Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy (NCT NCT03290378)
NCT ID: NCT03290378
Last Updated: 2020-03-19
Results Overview
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
409 participants
Primary outcome timeframe
48 hours post first dose
Results posted on
2020-03-19
Participant Flow
Participant milestones
| Measure |
AVE-901 50 mg
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
AVE-901 25 mg
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
Placebo
Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
|---|---|---|---|
|
Overall Study
STARTED
|
140
|
133
|
136
|
|
Overall Study
COMPLETED
|
137
|
123
|
120
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Baseline characteristics by cohort
| Measure |
AVE-901 50 mg
n=139 Participants
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
AVE-901 25 mg
n=134 Participants
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
Placebo
n=136 Participants
Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
Total
n=409 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 13.15 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 13.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
349 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
280 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
139 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
409 Participants
n=4 Participants
|
|
Previous opioid history
Yes
|
42 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Previous opioid history
No
|
97 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
268 Participants
n=4 Participants
|
|
American Society of Anesthesiology (ASA) Physical Classification
1
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
|
American Society of Anesthesiology (ASA) Physical Classification
2
|
69 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Qualifying Categorical Pain Score
Moderate
|
89 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
244 Participants
n=4 Participants
|
|
Qualifying Categorical Pain Score
Severe
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
BMI
|
27.9 kg/m2
STANDARD_DEVIATION 4.97 • n=5 Participants
|
28.1 kg/m2
STANDARD_DEVIATION 5.48 • n=7 Participants
|
28.3 kg/m2
STANDARD_DEVIATION 4.91 • n=5 Participants
|
28.1 kg/m2
STANDARD_DEVIATION 5.12 • n=4 Participants
|
|
Qualifying Numerical Pain Rating Scale (NPRS)
|
6.7 score on a scale
STANDARD_DEVIATION 1.66 • n=5 Participants
|
6.8 score on a scale
STANDARD_DEVIATION 1.39 • n=7 Participants
|
6.9 score on a scale
STANDARD_DEVIATION 1.63 • n=5 Participants
|
6.8 score on a scale
STANDARD_DEVIATION 1.56 • n=4 Participants
|
PRIMARY outcome
Timeframe: 48 hours post first dosePopulation: One patient was randomized to tramadol 25 mg but received tramadol 50 mg in error.
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.
Outcome measures
| Measure |
AVE-901 50 mg
n=139 Participants
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
AVE-901 25 mg
n=134 Participants
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
Placebo
n=136 Participants
Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
|---|---|---|---|
|
The Sum of Pain Intensity Differences (SPID) Through 48 Hours Post First Dose
|
-122.8 score on a scale
Interval -135.14 to -110.5
|
-110.9 score on a scale
Interval -123.64 to -98.17
|
-97.8 score on a scale
Interval -110.6 to -85.0
|
Adverse Events
AVE-901 50 mg
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
AVE-901 25 mg
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AVE-901 50 mg
n=140 participants at risk
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
AVE-901 25 mg
n=133 participants at risk
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
Placebo
n=136 participants at risk
Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
|---|---|---|---|
|
General disorders
non-cardiac chest pain
|
0.00%
0/140 • 6 months
|
0.75%
1/133 • 6 months
|
0.00%
0/136 • 6 months
|
Other adverse events
| Measure |
AVE-901 50 mg
n=140 participants at risk
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
AVE-901 25 mg
n=133 participants at risk
Tramadol: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
Placebo
n=136 participants at risk
Placebo: IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
32.1%
45/140 • 6 months
|
9.0%
12/133 • 6 months
|
8.1%
11/136 • 6 months
|
|
Nervous system disorders
Headache
|
5.7%
8/140 • 6 months
|
10.5%
14/133 • 6 months
|
9.6%
13/136 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
28/140 • 6 months
|
3.0%
4/133 • 6 months
|
3.7%
5/136 • 6 months
|
|
Nervous system disorders
Dizziness
|
15.0%
21/140 • 6 months
|
5.3%
7/133 • 6 months
|
2.9%
4/136 • 6 months
|
|
General disorders
Infusion Site Pain
|
7.9%
11/140 • 6 months
|
3.8%
5/133 • 6 months
|
7.4%
10/136 • 6 months
|
|
Nervous system disorders
Somnolence
|
11.4%
16/140 • 6 months
|
4.5%
6/133 • 6 months
|
2.2%
3/136 • 6 months
|
|
General disorders
Infusion site extravasation
|
3.6%
5/140 • 6 months
|
5.3%
7/133 • 6 months
|
3.7%
5/136 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
5.7%
8/140 • 6 months
|
2.3%
3/133 • 6 months
|
2.2%
3/136 • 6 months
|
|
Gastrointestinal disorders
Pruritus generalized
|
2.9%
4/140 • 6 months
|
2.3%
3/133 • 6 months
|
0.74%
1/136 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
5/140 • 6 months
|
0.00%
0/133 • 6 months
|
0.74%
1/136 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/140 • 6 months
|
2.3%
3/133 • 6 months
|
1.5%
2/136 • 6 months
|
|
Gastrointestinal disorders
Decreased Appetite
|
0.00%
0/140 • 6 months
|
0.75%
1/133 • 6 months
|
2.2%
3/136 • 6 months
|
|
Nervous system disorders
Muscle Twitching
|
0.00%
0/140 • 6 months
|
2.3%
3/133 • 6 months
|
0.74%
1/136 • 6 months
|
|
General disorders
Rash
|
0.00%
0/140 • 6 months
|
2.3%
3/133 • 6 months
|
0.00%
0/136 • 6 months
|
Additional Information
VP of Clinical Operations and Program Management
Avenue Therapeutics
Phone: 781-652-4514
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place