Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo (NCT NCT01813890)
NCT ID: NCT01813890
Last Updated: 2015-01-09
Results Overview
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
COMPLETED
PHASE3
60 participants
48 hours
2015-01-09
Participant Flow
The study was conducted from 11 January 2013 to 12 January 2014. Participants were recruited at 3 study centers in Taiwan.
Participant milestones
| Measure |
Placebo
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
19
|
|
Overall Study
COMPLETED
|
11
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
9
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 14.98 • n=93 Participants
|
42.3 years
STANDARD_DEVIATION 14.27 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 11.81 • n=27 Participants
|
43.3 years
STANDARD_DEVIATION 13.59 • n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age Customized
Less than (<) 65 years
|
18 participants
n=93 Participants
|
20 participants
n=4 Participants
|
18 participants
n=27 Participants
|
56 participants
n=483 Participants
|
|
Age Customized
Greater than or equal (>=) to 65 years
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
4 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Intent-to-treat (ITT) analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID) Over 48 Hours
|
50.8 units on a scale
Standard Deviation 158.52
|
168.4 units on a scale
Standard Deviation 84.50
|
194.9 units on a scale
Standard Deviation 131.13
|
SECONDARY outcome
Timeframe: up to 48 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.
Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Time to First Rescue Medication Use
|
NA Hours
Inter-Quartile Range 84.50 • Interval 8.1 to
The median time to the first rescue medication could not be calculated for the treatment group because only 50 percent of participants used rescue medication.
|
NA Hours
Inter-Quartile Range 131.13
The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent (1 \[4.8 percent\]) of participants used rescue medication.
|
NA Hours
Inter-Quartile Range 158.52
The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent (2 \[10.5 percent\]) of participants used rescue medication.
|
SECONDARY outcome
Timeframe: 12, 24, 48 and 72 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.
Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
12 hours
|
35.0 Percentage of Participants
|
66.7 Percentage of Participants
|
73.7 Percentage of Participants
|
|
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
24 hours
|
40.0 Percentage of Participants
|
66.7 Percentage of Participants
|
73.7 Percentage of Participants
|
|
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
48 hours
|
45.0 Percentage of Participants
|
81.0 Percentage of Participants
|
68.4 Percentage of Participants
|
|
Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
72 hours
|
45.0 Percentage of Participants
|
81.0 Percentage of Participants
|
68.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 12, 24, 48 and 72 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.
Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
12 hours
|
20.0 Percentage of Participants
|
42.9 Percentage of Participants
|
57.9 Percentage of Participants
|
|
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
24 hours
|
35.0 Percentage of Participants
|
61.9 Percentage of Participants
|
73.7 Percentage of Participants
|
|
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
48 hours
|
40.0 Percentage of Participants
|
76.2 Percentage of Participants
|
68.4 Percentage of Participants
|
|
Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours
72 hours
|
45.0 Percentage of Participants
|
81.0 Percentage of Participants
|
68.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 12, 24 and 72 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours
12 hours
|
7.6 units on a scale
Standard Deviation 32.22
|
30.3 units on a scale
Standard Deviation 17.24
|
34.7 units on a scale
Standard Deviation 25.70
|
|
Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours
24 hours
|
16.7 units on a scale
Standard Deviation 69.37
|
67.5 units on a scale
Standard Deviation 40.90
|
82.0 units on a scale
Standard Deviation 57.65
|
|
Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours
72 hours
|
91.6 units on a scale
Standard Deviation 252.89
|
281.3 units on a scale
Standard Deviation 129.48
|
316.1 units on a scale
Standard Deviation 206.81
|
SECONDARY outcome
Timeframe: 12, 24, 48, and 72 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.
Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
72 hours
|
112.6 units on a scale
Standard Deviation 103.19
|
187.3 units on a scale
Standard Deviation 68.03
|
194.1 units on a scale
Standard Deviation 74.63
|
|
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
12 hours
|
13.0 units on a scale
Standard Deviation 11.29
|
22.5 units on a scale
Standard Deviation 10.27
|
24.4 units on a scale
Standard Deviation 10.33
|
|
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
24 hours
|
28.0 units on a scale
Standard Deviation 24.50
|
48.2 units on a scale
Standard Deviation 22.07
|
54.1 units on a scale
Standard Deviation 20.47
|
|
Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
48 hours
|
68.2 units on a scale
Standard Deviation 62.26
|
115.6 units on a scale
Standard Deviation 45.06
|
123.5 units on a scale
Standard Deviation 49.99
|
SECONDARY outcome
Timeframe: 12, 24, 48 and 72 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.
Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
12 hours
|
20.7 units on a scale
Standard Deviation 41.51
|
52.8 units on a scale
Standard Deviation 25.66
|
59.1 units on a scale
Standard Deviation 33.20
|
|
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
48 hours
|
119.1 units on a scale
Standard Deviation 214.14
|
284.0 units on a scale
Standard Deviation 122.07
|
318.4 units on a scale
Standard Deviation 171.50
|
|
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
72 hours
|
204.3 units on a scale
Standard Deviation 346.52
|
468.6 units on a scale
Standard Deviation 185.43
|
510.2 units on a scale
Standard Deviation 268.96
|
|
Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
24 hours
|
44.7 units on a scale
Standard Deviation 90.14
|
115.7 units on a scale
Standard Deviation 59.74
|
136.0 units on a scale
Standard Deviation 72.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and 72 hoursPopulation: ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.
The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 Participants
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 Participants
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Much Worse
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Very Much Improved
|
40.0 Percentage of participants
|
71.4 Percentage of participants
|
73.7 Percentage of participants
|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Much Improved
|
10.0 Percentage of participants
|
14.3 Percentage of participants
|
5.3 Percentage of participants
|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Minimally Improved
|
5.0 Percentage of participants
|
9.5 Percentage of participants
|
10.5 Percentage of participants
|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
No Change
|
20.0 Percentage of participants
|
4.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Minimally Worse
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Patient Global Impression of Change (PGI-C) Score at 72 Hours
Very Much Worse
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
10.5 Percentage of participants
|
Adverse Events
Placebo
Tapentadol IR 50 mg
Tapentadol IR 75 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
|
Tapentadol IR 50 mg
n=21 participants at risk
Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
|
Tapentadol IR 75 mg
n=19 participants at risk
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20
|
4.8%
1/21
|
0.00%
0/19
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
|
33.3%
7/21
|
42.1%
8/19
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
19.0%
4/21
|
52.6%
10/19
|
|
General disorders
Chest discomfort
|
0.00%
0/20
|
0.00%
0/21
|
5.3%
1/19
|
|
General disorders
Pyrexia
|
10.0%
2/20
|
14.3%
3/21
|
10.5%
2/19
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/20
|
9.5%
2/21
|
0.00%
0/19
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20
|
66.7%
14/21
|
84.2%
16/19
|
|
Nervous system disorders
Headache
|
5.0%
1/20
|
14.3%
3/21
|
10.5%
2/19
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20
|
14.3%
3/21
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
5.0%
1/20
|
0.00%
0/21
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20
|
0.00%
0/21
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20
|
0.00%
0/21
|
5.3%
1/19
|
Additional Information
Mila Etropolski, Clinical Leader
Janssen Research & Development, L.L.C.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60