Trial Outcomes & Findings for Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery (NCT NCT03395808)

Last Updated: 2021-03-09

Results Overview

Reported Adverse Events

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

251 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2021-03-09

Participant milestones
Measure	AVE-901 50mg IV Tramadol Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
Overall Study STARTED	251
Overall Study COMPLETED	251
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery

Baseline characteristics by cohort
Measure	AVE-901 50mg n=251 Participants IV Tramadol Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	201 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants
Race (NIH/OMB) White	203 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	251 participants n=5 Participants

Timeframe: Up to 21 days

Reported Adverse Events

Outcome measures
Measure	IV Tramadol 50 mg n=251 Participants 50 mg IV tramadol given at 0, 2, 4 hours and every 4 hours after
Adverse Events	251 Participants

Serious events: 2 serious events

Other events: 149 other events

Deaths: 0 deaths

Serious adverse events
Measure	AVE-901 50mg n=251 participants at risk IV Tramadol Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
Investigations Post procedural hematoma	0.80% 2/251 • Number of events 2 • 6 months

Other adverse events
Measure	AVE-901 50mg n=251 participants at risk IV Tramadol Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
Gastrointestinal disorders Nausea	28.7% 72/251 • 6 months
Gastrointestinal disorders Vomitting	19.5% 49/251 • 6 months
Respiratory, thoracic and mediastinal disorders Hypoxia	6.8% 17/251 • 6 months
Investigations Blood creatine phosphokinase increased	6.4% 16/251 • 6 months
Gastrointestinal disorders Constipation	5.6% 14/251 • 6 months
General disorders Infusion Site pain	5.2% 13/251 • 6 months

Avenue Therapeutics

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