Trial Outcomes & Findings for Maxigesic® IV Phase 3 Exposure Study (NCT NCT04005755)
NCT ID: NCT04005755
Last Updated: 2021-09-01
Results Overview
The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV
COMPLETED
PHASE3
232 participants
During treatment period (≥ 48 hours - 5 days)
2021-09-01
Participant Flow
323 subjects were screened, of whom 90 subjects were screening failures, and a total of 233 subjects were enrolled. 1 subject was enrolled but not dosed due to receiving prohibited concomitant medications during surgery, therefore a total of 232 subjects were administered at least one dose of the study drug. 17 subjects discontinued from the study, including 14 discontinuations during the treatment period, and 3 discontinuations during the follow-up period. 215 subjects completed the full study
Participant milestones
| Measure |
Maxigesic® IV
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Overall Study
STARTED
|
232
|
|
Overall Study
COMPLETED
|
215
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Maxigesic® IV
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Administrative reason, temporary site closure due to COVID-19
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Maxigesic® IV Phase 3 Exposure Study
Baseline characteristics by cohort
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
171 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=39 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 15.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
223 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
91 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
New Zealand
|
85 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=39 Participants
|
|
BMI
|
29.7 kg/m^2
STANDARD_DEVIATION 5.5 • n=39 Participants
|
PRIMARY outcome
Timeframe: During treatment period (≥ 48 hours - 5 days)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Incidence of TEAEs (Treatment-emergent Adverse Events)
Incidence of TEAEs ( 2 days treatment)
|
256 Treatment-Emergent Adverse Events
|
|
Incidence of TEAEs (Treatment-emergent Adverse Events)
Incidence of TEAEs (5 days treatment)
|
38 Treatment-Emergent Adverse Events
|
SECONDARY outcome
Timeframe: After receiving the first dose of study medication until 7 days after the last dose, a total of approximately 9 days for subjects who received the treatment for 48 hours and 12 days for subjects who received the treatment for 5 days.Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
The incidence of treatment-emergent adverse events associated with exposure Maxigesic® IV during various study time periods
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Time Course of TEAEs
Treatment-Emergent Adverse Events Day 1
|
166 Treatment-Emergent Adverse Events
|
|
Time Course of TEAEs
Treatment-Emergent Adverse Events Day 2
|
90 Treatment-Emergent Adverse Events
|
|
Time Course of TEAEs
Treatment-Emergent Adverse Events Day 3
|
9 Treatment-Emergent Adverse Events
|
|
Time Course of TEAEs
Treatment-Emergent Adverse Events Day 4
|
12 Treatment-Emergent Adverse Events
|
|
Time Course of TEAEs
Treatment-Emergent Adverse Events Day 5
|
17 Treatment-Emergent Adverse Events
|
SECONDARY outcome
Timeframe: During treatment period (≥ 48 hours - 5 days)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
The incidence of treatment-related adverse events (TEAEs considered by the investigator to be "probably" or "definitely" related to the study drug) associated with exposure Maxigesic® IV
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Incidence of TRAEs (Treatment-related Adverse Events)
Not related
|
103 Treatment-Emergent Adverse Events
|
|
Incidence of TRAEs (Treatment-related Adverse Events)
Unlikely
|
89 Treatment-Emergent Adverse Events
|
|
Incidence of TRAEs (Treatment-related Adverse Events)
Possible
|
34 Treatment-Emergent Adverse Events
|
|
Incidence of TRAEs (Treatment-related Adverse Events)
Probable
|
17 Treatment-Emergent Adverse Events
|
|
Incidence of TRAEs (Treatment-related Adverse Events)
Definite
|
51 Treatment-Emergent Adverse Events
|
SECONDARY outcome
Timeframe: During treatment period (≥ 48 hours - 5 days)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
The incidence of TEAEs of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Incidence of TEAEs of Interest
Gastrointestinal disorders
|
67 Treatment-Emergent Adverse Events
|
|
Incidence of TEAEs of Interest
Renal and urinary disorders
|
12 Treatment-Emergent Adverse Events
|
|
Incidence of TEAEs of Interest
Abnormal hepatic function lab results
|
25 Treatment-Emergent Adverse Events
|
|
Incidence of TEAEs of Interest
General disorders and administration site conditions
|
78 Treatment-Emergent Adverse Events
|
|
Incidence of TEAEs of Interest
Cardiac Disorders
|
3 Treatment-Emergent Adverse Events
|
|
Incidence of TEAEs of Interest
Vascular disorders
|
7 Treatment-Emergent Adverse Events
|
SECONDARY outcome
Timeframe: From the baseline (Day 1 prior to surgery) until 7 days after the last dosePopulation: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Systolic and Diastolic Blood Pressured Measured every 24 hours
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Pressure
Systolic Blood Pressure change from the baseline
|
-0.9 mmHg
Standard Deviation 18.98
|
|
Changes in Blood Pressure
Diastolic Blood Pressure change from the baseline
|
-0.5 mmHg
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: From the baseline (Day 1 prior to surgery) until 7 days after the last dosePopulation: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured every 24 hours
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Heart Rate
|
3.4 beats/min
Standard Deviation 11.86
|
SECONDARY outcome
Timeframe: From the baseline (Day 1 prior to surgery) until 7 days after the last dosePopulation: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured every 24 hours
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Temperature
|
0.2 degree Celsius
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: From the baseline (Day 1 prior to surgery) until 7 days after the last dosePopulation: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Respiratory Rate Measured every 24 hours
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Respiratory Rate
|
0.5 breaths/min
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hematology Values (Hemoglobin)
|
-11.6 g/L
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hematology Values (Hematocrit)
|
-0.03 proportion of red blood cells in blood
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hematology Values (Platelet Count)
|
-12.8 billions/L
Standard Deviation 40.1
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hematology Values (Red Blood Cell Count)
|
-0.4 trillions/L
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hematology Values (White Blood Cell Count)
|
6.2 billions/L
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received
Hematology test was Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hematology Values (Differential Leukocyte Count)
Basophils
|
-0.00 billions/L
Standard Deviation 0.02
|
|
Changes in Hematology Values (Differential Leukocyte Count)
Eosinophils
|
0.05 billions/L
Standard Deviation 0.13
|
|
Changes in Hematology Values (Differential Leukocyte Count)
Lymphocytes
|
-0.2 billions/L
Standard Deviation 0.5
|
|
Changes in Hematology Values (Differential Leukocyte Count)
Monocytes
|
0.2 billions/L
Standard Deviation 0.2
|
|
Changes in Hematology Values (Differential Leukocyte Count)
Neutrophils
|
1.5 billions/L
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Sodium)
|
-0.6 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Potassium)
|
-0.1 mmol/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Urea)
|
-0.7 mmol/L
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Creatinine)
|
-3.9 μmol/L
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Phosphate)
|
-0.1 mmol/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Glucose)
|
0.7 mmol/L
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Albumin)
|
-4.9 g/L
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Total Protein)
|
-5.8 g/L
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Alkaline Phosphates)
|
-2.1 IU/L
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Blood Biochemistry was Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Gamma-glutamyl Transferase)
|
4.3 IU/L
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Blood Chemistry (AST) was Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Aspartate Transaminase)
|
7.1 IU/L
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Blood Chemistry (ALT) was Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Alanine Transaminase)
|
4.5 IU/L
Standard Deviation 25.2
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Measured at screening visit and at the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Blood Biochemistry Values (Bilirubin)
|
0.0 μmol/L
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
All components of the ECG will be analysed to assess safety (P wave, QRS Complex, QT interval, PR interval, T wave, ST segment, U wave, PR segment) in 5 categories of the shift from baseline to the end of treatment from: Normal to Normal Normal to Abnormal NCS (Non-clinically Significant) Abnormal NCS to Normal Abnormal NCS to Abnormal NCS Missing
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Shift from Baseline to the end of treatment Missing
|
2 Participants
|
|
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Shift from Baseline to the end of treatment Normal to Normal
|
83 Participants
|
|
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Shift from Baseline to the end of treatment Normal to Abnormal NCS
|
18 Participants
|
|
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Shift from Baseline to the end of treatment Abnormal NCS to Normal
|
44 Participants
|
|
Changes in ECG (Electrocardiography) Status (Normal/Abnormal)
Shift from Baseline to the end of treatment Abnormal NCS to Abnormal NCS
|
85 Participants
|
SECONDARY outcome
Timeframe: Prior to surgery, on Day 1 and at discharge (Day 5)Population: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received. The number of participants analyzed are reporting the number of participants who experienced the shifts from Normal to Abnormal.
The elevation in hepatic enzymes (ALP, ALT, AST, GGT) from baseline to the end of the treatment
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shifts from Normal to High Upper Limit of Normal (ULN) <3.0 · ALP
|
1 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shifts from Normal to High Upper Limit of Normal (ULN) <3.0 · ALT
|
24 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shifts from Normal to High Upper Limit of Normal (ULN) <3.0 · AST
|
22 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shifts from Normal to High Upper Limit of Normal (ULN) <3.0 · GGT
|
12 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 3.0, <5.0 · ALP
|
0 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 3.0, <5.0 · ALT
|
4 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 3.0, <5.0 · AST
|
5 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 3.0, <5.0 · GGT
|
0 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 5.0 · ALP
|
0 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 5.0 · ALT
|
2 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 5.0 · AST
|
0 Participants
|
|
Changes in Hepatic Enzymes From Baseline to the End of the Treatment
Shift from Normal to High ULN ≥ 5.0 · GGT
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 days after the first dosePopulation: The safety analysis was on all participants who were administered at least one dose of study medication, with treatment allocation for analysis based on the actual treatment the participant received.
Summary of the patients' ratings of the study medication (1 = Poor; 2 = Fair; 3 = Good; 4 = Very Good; 5 = Excellent)
Outcome measures
| Measure |
Maxigesic® IV
n=232 Participants
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Patient's Global Evaluation of the Study Drug
Poor
|
4 Participants
|
|
Patient's Global Evaluation of the Study Drug
Fair
|
12 Participants
|
|
Patient's Global Evaluation of the Study Drug
Good
|
40 Participants
|
|
Patient's Global Evaluation of the Study Drug
Very Good
|
82 Participants
|
|
Patient's Global Evaluation of the Study Drug
Excellent
|
93 Participants
|
|
Patient's Global Evaluation of the Study Drug
Missing
|
1 Participants
|
Adverse Events
Maxigesic® IV
Serious adverse events
| Measure |
Maxigesic® IV
n=232 participants at risk
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
Vascular disorders
hypotension
|
0.43%
1/232 • Number of events 1 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Gastrointestinal disorders
bowel obstruction
|
0.43%
1/232 • Number of events 1 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
Other adverse events
| Measure |
Maxigesic® IV
n=232 participants at risk
Acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion. The study drug will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes. The study drug will be administered every 6 hours (q6h) for a minimum of 48 hours up to at least 5 days, with a maximum of 4 doses within a 24 hour period.
Maxigesic® IV: acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
|
|---|---|
|
General disorders
Infusion site pain
|
19.0%
44/232 • Number of events 49 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Gastrointestinal disorders
Nausea
|
12.1%
28/232 • Number of events 32 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
General disorders
Infusion site extravasation
|
7.8%
18/232 • Number of events 19 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Gastrointestinal disorders
Constipation
|
7.8%
18/232 • Number of events 19 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Nervous system disorders
Headache
|
5.6%
13/232 • Number of events 13 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Nervous system disorders
Dizziness
|
3.9%
9/232 • Number of events 12 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Renal and urinary disorders
Polyuria
|
3.9%
9/232 • Number of events 9 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
3.4%
8/232 • Number of events 8 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Nervous system disorders
Somnolence
|
3.0%
7/232 • Number of events 7 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Nervous system disorders
Diarrhoea
|
2.2%
5/232 • Number of events 5 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
2.2%
5/232 • Number of events 5 • During the treatment period (after receiving the first dose of study medication until 7 days after the last dose, a total of approximately 12 days)
Treatment-emergent adverse events (TEAEs): Treatment-emergent adverse events (TEAEs) were defined as events that emerged during treatment, having been absent pre-treatment, or that worsened relative to the pre-treatment status. The definition of serious adverse events and reporting requirement are determined in the study protocol section 8.1.2 and section 8.4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place