Trial Outcomes & Findings for A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain (NCT NCT01814878)
NCT ID: NCT01814878
Last Updated: 2013-06-20
Results Overview
The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score \>=1 and \<=3, PI score of 2=NRS score of \>=4 and \<=6 and PI score of 3=NRS score of \>=7 and \<=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).
COMPLETED
PHASE3
320 participants
Hour 48
2013-06-20
Participant Flow
Participant milestones
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
158
|
|
Overall Study
COMPLETED
|
116
|
128
|
|
Overall Study
NOT COMPLETED
|
46
|
30
|
Reasons for withdrawal
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
5
|
|
Overall Study
Withdrawal by Subject
|
20
|
16
|
|
Overall Study
Protocol Violation
|
5
|
5
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Screening failure (drop-out)
|
0
|
3
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain
Baseline characteristics by cohort
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=162 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=158 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.8 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
67.5 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
67.1 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 48Population: The per-protocol (PP) population included all randomly assigned participants who did not violate major eligibility criteria and whose SPID was calculated with actual measurements or adjusted values at all assessment time points.
The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score \>=1 and \<=3, PI score of 2=NRS score of \>=4 and \<=6 and PI score of 3=NRS score of \>=7 and \<=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=139 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=127 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Sum of Pain Intensity Difference (SPID) at Hour 48
|
32.5 Units on scale
Standard Deviation 30.7
|
37.2 Units on scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Hour 6, 12, 24Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' (number of participants analyzed) specifies those participants who were evaluable for this outcome measure.
The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score \>=1 and \<=3, PI score of 2=NRS score of \>=4 and \<=6 and PI score of 3=NRS score of \>=7 and \<=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=162 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=155 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24
Hour 6
|
3.6 Units on scale
Standard Deviation 3.7
|
3.9 Units on scale
Standard Deviation 3.3
|
|
Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24
Hour 12
|
7.0 Units on scale
Standard Deviation 7.8
|
8.1 Units on scale
Standard Deviation 6.5
|
|
Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24
Hour 24
|
14.6 Units on scale
Standard Deviation 15.3
|
17.6 Units on scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Hour 6, 12, 24, 48Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.
Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=161 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=151 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Total Pain Relief (TOTPAR) Score
Hour 6
|
6.0 Units on scale
Standard Deviation 4.8
|
6.8 Units on scale
Standard Deviation 5.7
|
|
Total Pain Relief (TOTPAR) Score
Hour 12
|
12.5 Units on scale
Standard Deviation 10.4
|
14.7 Units on scale
Standard Deviation 11.1
|
|
Total Pain Relief (TOTPAR) Score
Hour 24
|
27.1 Units on scale
Standard Deviation 21.3
|
31.0 Units on scale
Standard Deviation 22.5
|
|
Total Pain Relief (TOTPAR) Score
Hour 48
|
55.6 Units on scale
Standard Deviation 43.2
|
61.7 Units on scale
Standard Deviation 44.5
|
SECONDARY outcome
Timeframe: Hour 6, 12, 24, 48Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.
The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score \>=1 and \<= 3, PI score of 2=NRS score of \>=4 and \<=6 and PI score of 3=NRS score of \>=7 and \<=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=161 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=151 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)
Hour 6
|
9.6 Units on scale
Standard Deviation 7.3
|
10.9 Units on scale
Standard Deviation 8.1
|
|
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)
Hour 12
|
19.6 Units on scale
Standard Deviation 15.7
|
23.1 Units on scale
Standard Deviation 15.2
|
|
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)
Hour 24
|
41.8 Units on scale
Standard Deviation 31.6
|
49.1 Units on scale
Standard Deviation 30.8
|
|
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)
Hour 48
|
85.9 Units on scale
Standard Deviation 64.7
|
97.0 Units on scale
Standard Deviation 61.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 3Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.
The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular \[directly into muscle\] or intravenous injection \[directly into vein\]).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=29 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=30 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Time to the First Rescue Medication Administered Because of Insufficient Pain Relief
|
1339 Minutes
Standard Deviation 710
|
1212 Minutes
Standard Deviation 853
|
SECONDARY outcome
Timeframe: Baseline up to Day 3Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.
The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=29 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=30 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief
|
2.1 Doses
Standard Deviation 1.9
|
1.4 Doses
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline up to Day 3Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.
The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=29 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=30 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Dosage of Rescue Medication Administered Because of Insufficient Pain Relief
|
50.0 Milligram
Standard Deviation 0.0
|
51.7 Milligram
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Day 3Population: The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.
The PGIC was used to assess the degree of participant's overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=134 Participants
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=138 Participants
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Score
|
2.71 Units on scale
Standard Deviation 0.86
|
2.60 Units on scale
Standard Deviation 0.80
|
Adverse Events
Tramadol Hydrochloride (HCl)/Acetaminophen ER
Tramadol HCl/Acetaminophen IR
Serious adverse events
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=161 participants at risk
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=153 participants at risk
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.62%
1/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
0.00%
0/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
Other adverse events
| Measure |
Tramadol Hydrochloride (HCl)/Acetaminophen ER
n=161 participants at risk
Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
|
Tramadol HCl/Acetaminophen IR
n=153 participants at risk
Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
24.2%
39/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
19.6%
30/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
11/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
13.1%
20/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Gastrointestinal disorders
Nausea
|
49.7%
80/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
44.4%
68/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
45/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
24.2%
37/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
General disorders
Pyrexia
|
17.4%
28/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
23.5%
36/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
6.8%
11/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
3.9%
6/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Investigations
Haemoglobin decreased
|
23.6%
38/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
26.1%
40/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Nervous system disorders
Dizziness
|
10.6%
17/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
8.5%
13/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Nervous system disorders
Headache
|
9.3%
15/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
5.9%
9/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Renal and urinary disorders
Dysuria
|
16.8%
27/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
15.7%
24/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.5%
33/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
17.0%
26/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Nervous system disorders
Somnolence
|
5.6%
9/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
5.2%
8/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
|
Psychiatric disorders
Insomnia
|
5.0%
8/161 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
0.65%
1/153 • Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
|
Additional Information
Clinical Research Director
Janssen Korea/25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is cancelled.
- Publication restrictions are in place
Restriction type: OTHER