Trial Outcomes & Findings for Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (NCT NCT01902134)
NCT ID: NCT01902134
Last Updated: 2016-03-07
Results Overview
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
641 participants
Primary outcome timeframe
over 8 hours after the first dose
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
DKP/TRAM Followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
|
DKP Followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
|
TRAM Followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
|
Placebo Followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
|
Placebo Followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
|
Placebo Followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
159
|
161
|
160
|
54
|
53
|
54
|
|
Overall Study
Single-dose Phase
|
159
|
161
|
160
|
54
|
53
|
54
|
|
Overall Study
Multiple-dose Phase
|
159
|
160
|
160
|
54
|
53
|
52
|
|
Overall Study
COMPLETED
|
151
|
150
|
145
|
52
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
15
|
2
|
7
|
9
|
Reasons for withdrawal
| Measure |
DKP/TRAM Followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
|
DKP Followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
|
TRAM Followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
|
Placebo Followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
|
Placebo Followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
|
Placebo Followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
2
|
1
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
9
|
1
|
5
|
4
|
|
Overall Study
no compliance
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
2
|
0
|
1
|
0
|
Baseline Characteristics
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Baseline characteristics by cohort
| Measure |
DKP/TRAM Followed by DKP/TRAM
n=159 Participants
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
|
DKP Followed by DKP
n=161 Participants
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
|
TRAM Followed by TRAM
n=160 Participants
Tramadol-single dose followed by Tramadol-multiple doses
|
Placebo Followed by DKP/TRAM
n=54 Participants
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
|
Placebo Followed by DKP
n=53 Participants
Placebo single dose followed by Dexketoprofen-multiple doses
|
Placebo Followed by TRAM
n=54 Participants
Placebo single dose followed by Tramadol-multiple doses
|
Total
n=641 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.43 • n=39 Participants
|
63.3 years
STANDARD_DEVIATION 9.01 • n=41 Participants
|
61.3 years
STANDARD_DEVIATION 9.68 • n=35 Participants
|
63.9 years
STANDARD_DEVIATION 9.0 • n=31 Participants
|
61.0 years
STANDARD_DEVIATION 11.10 • n=146 Participants
|
59.8 years
STANDARD_DEVIATION 11.30 • n=19 Participants
|
61.9 years
STANDARD_DEVIATION 9.96 • n=147 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=39 Participants
|
86 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
37 Participants
n=31 Participants
|
33 Participants
n=146 Participants
|
24 Participants
n=19 Participants
|
346 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
20 Participants
n=146 Participants
|
30 Participants
n=19 Participants
|
295 Participants
n=147 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=39 Participants
|
2 participants
n=41 Participants
|
3 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
2 participants
n=19 Participants
|
7 participants
n=147 Participants
|
|
Race/Ethnicity, Customized
White
|
159 participants
n=39 Participants
|
159 participants
n=41 Participants
|
157 participants
n=35 Participants
|
54 participants
n=31 Participants
|
53 participants
n=146 Participants
|
52 participants
n=19 Participants
|
634 participants
n=147 Participants
|
|
Region of Enrollment
Serbia
|
15 participants
n=39 Participants
|
18 participants
n=41 Participants
|
14 participants
n=35 Participants
|
5 participants
n=31 Participants
|
5 participants
n=146 Participants
|
5 participants
n=19 Participants
|
62 participants
n=147 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=39 Participants
|
2 participants
n=41 Participants
|
3 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
2 participants
n=19 Participants
|
7 participants
n=147 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=39 Participants
|
10 participants
n=41 Participants
|
8 participants
n=35 Participants
|
2 participants
n=31 Participants
|
4 participants
n=146 Participants
|
3 participants
n=19 Participants
|
36 participants
n=147 Participants
|
|
Region of Enrollment
Hungary
|
49 participants
n=39 Participants
|
57 participants
n=41 Participants
|
54 participants
n=35 Participants
|
17 participants
n=31 Participants
|
16 participants
n=146 Participants
|
11 participants
n=19 Participants
|
204 participants
n=147 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
0 participants
n=19 Participants
|
2 participants
n=147 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=39 Participants
|
8 participants
n=41 Participants
|
8 participants
n=35 Participants
|
2 participants
n=31 Participants
|
2 participants
n=146 Participants
|
3 participants
n=19 Participants
|
33 participants
n=147 Participants
|
|
Region of Enrollment
Ukraine
|
15 participants
n=39 Participants
|
13 participants
n=41 Participants
|
13 participants
n=35 Participants
|
6 participants
n=31 Participants
|
6 participants
n=146 Participants
|
3 participants
n=19 Participants
|
56 participants
n=147 Participants
|
|
Region of Enrollment
Lithuania
|
22 participants
n=39 Participants
|
19 participants
n=41 Participants
|
21 participants
n=35 Participants
|
6 participants
n=31 Participants
|
5 participants
n=146 Participants
|
11 participants
n=19 Participants
|
84 participants
n=147 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
0 participants
n=31 Participants
|
0 participants
n=146 Participants
|
0 participants
n=19 Participants
|
4 participants
n=147 Participants
|
|
Region of Enrollment
Latvia
|
37 participants
n=39 Participants
|
33 participants
n=41 Participants
|
36 participants
n=35 Participants
|
16 participants
n=31 Participants
|
15 participants
n=146 Participants
|
16 participants
n=19 Participants
|
153 participants
n=147 Participants
|
|
Weight
|
83.3 kg
STANDARD_DEVIATION 15.37 • n=39 Participants
|
81.4 kg
STANDARD_DEVIATION 15.63 • n=41 Participants
|
83.5 kg
STANDARD_DEVIATION 17.25 • n=35 Participants
|
82.4 kg
STANDARD_DEVIATION 15.91 • n=31 Participants
|
81.7 kg
STANDARD_DEVIATION 13.77 • n=146 Participants
|
82.1 kg
STANDARD_DEVIATION 15.27 • n=19 Participants
|
82.6 kg
STANDARD_DEVIATION 15.80 • n=147 Participants
|
|
Height
|
168.8 cm
STANDARD_DEVIATION 8.99 • n=39 Participants
|
167.9 cm
STANDARD_DEVIATION 9.14 • n=41 Participants
|
169.1 cm
STANDARD_DEVIATION 9.20 • n=35 Participants
|
166.1 cm
STANDARD_DEVIATION 8.47 • n=31 Participants
|
168.0 cm
STANDARD_DEVIATION 9.49 • n=146 Participants
|
169.9 cm
STANDARD_DEVIATION 7.94 • n=19 Participants
|
168.5 cm
STANDARD_DEVIATION 9.01 • n=147 Participants
|
PRIMARY outcome
Timeframe: over 8 hours after the first doseSum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Outcome measures
| Measure |
DKP/TRAM
n=159 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
|
DEXKETOPROFEN
n=161 Participants
Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
|
TRAMADOL
n=160 Participants
Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
|
PLACEBO
n=161 Participants
Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
|
|---|---|---|---|---|
|
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
|
246.9 units on a scale
Standard Deviation 156.50
|
208.8 units on a scale
Standard Deviation 154.69
|
204.6 units on a scale
Standard Deviation 145.79
|
151.1 units on a scale
Standard Deviation 158.51
|
SECONDARY outcome
Timeframe: over 48 hours of the multiple-dose phaseSum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Outcome measures
| Measure |
DKP/TRAM
n=213 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
|
DEXKETOPROFEN
n=214 Participants
Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
|
TRAMADOL
n=214 Participants
Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
|
PLACEBO
Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
|
|---|---|---|---|---|
|
SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)
|
1943.7 units on a scale
Standard Deviation 1000.51
|
1677.5 units on a scale
Standard Deviation 1070.91
|
1765.6 units on a scale
Standard Deviation 963.49
|
—
|
SECONDARY outcome
Timeframe: over 48 hours of the multiple-dose phasePercentage of responders; response defined as achievement a mean pain intensity, PI-VAS \< 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase. The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
Outcome measures
| Measure |
DKP/TRAM
n=213 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
|
DEXKETOPROFEN
n=214 Participants
Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
|
TRAMADOL
n=214 Participants
Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
|
PLACEBO
Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
|
|---|---|---|---|---|
|
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
|
90.1 percentage of participants
|
76.6 percentage of participants
|
82.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: over 8 hours after the first dosePercentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
Outcome measures
| Measure |
DKP/TRAM
n=159 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
|
DEXKETOPROFEN
n=161 Participants
Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
|
TRAMADOL
n=160 Participants
Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
|
PLACEBO
n=161 Participants
Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
|
|---|---|---|---|---|
|
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
|
57.9 percentage of participants
|
56.5 percentage of participants
|
51.9 percentage of participants
|
37.9 percentage of participants
|
Adverse Events
DKP/TRAM Followed by DKP/TRAM
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
DKP Followed by DKP
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
TRAM Followed by TRAM
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo Followed by DKP/TRAM
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Followed by DKP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Followed by TRAM
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DKP/TRAM Followed by DKP/TRAM
n=159 participants at risk
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
|
DKP Followed by DKP
n=161 participants at risk
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
|
TRAM Followed by TRAM
n=160 participants at risk
Tramadol-single dose followed by Tramadol-multiple doses.
|
Placebo Followed by DKP/TRAM
n=54 participants at risk
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
|
Placebo Followed by DKP
n=53 participants at risk
Placebo single dose followed by Dexketoprofen-multiple doses.
|
Placebo Followed by TRAM
n=54 participants at risk
Placebo single dose followed by Tramadol-multiple doses.
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Bone operation
|
0.00%
0/159 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/161 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/160 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Surgical and medical procedures
Heart valve replacement
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Surgical and medical procedures
Vascular graft
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
General disorders
Device dislocation
|
0.00%
0/159 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/160 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
General disorders
Face oedema
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/159 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/161 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Cardiac disorders
Cardiac disorder
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/159 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/161 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/159 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
1.9%
1/54 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/159 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/161 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.63%
1/159 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/161 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/160 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
Other adverse events
| Measure |
DKP/TRAM Followed by DKP/TRAM
n=159 participants at risk
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
|
DKP Followed by DKP
n=161 participants at risk
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
|
TRAM Followed by TRAM
n=160 participants at risk
Tramadol-single dose followed by Tramadol-multiple doses.
|
Placebo Followed by DKP/TRAM
n=54 participants at risk
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
|
Placebo Followed by DKP
n=53 participants at risk
Placebo single dose followed by Dexketoprofen-multiple doses.
|
Placebo Followed by TRAM
n=54 participants at risk
Placebo single dose followed by Tramadol-multiple doses.
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
1.9%
3/159 • Number of events 3 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.6%
9/161 • Number of events 10 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
6.9%
11/160 • Number of events 12 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.6%
3/54 • Number of events 3 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
3.8%
2/53 • Number of events 3 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
7.4%
4/54 • Number of events 5 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
3/159 • Number of events 3 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/161 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.62%
1/160 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.6%
3/54 • Number of events 3 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
1.9%
1/54 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
4.4%
7/159 • Number of events 7 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
3.7%
6/161 • Number of events 6 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
3.1%
5/160 • Number of events 5 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.6%
3/54 • Number of events 3 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/159 • Number of events 2 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
2.5%
4/161 • Number of events 4 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.6%
9/160 • Number of events 9 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
1.9%
1/54 • Number of events 1 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/53 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.00%
0/54 • Study duration for patients was up to 6 weeks.
Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
Additional Information
Dr. Angela Capriati, Corporate Director of Clinical Research
Menarini Ricerche S.p.A.
Phone: +3905556809933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting the results of this study for publication or presentation, the PI will allow the Sponsor at least 60 days to review and comment upon the publication manuscript. The Sponsor will provide any manuscript of the results of this study at least 60 days before publishing to the authors for a complete review.
- Publication restrictions are in place
Restriction type: OTHER