Trial Outcomes & Findings for Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (NCT NCT01904149)
NCT ID: NCT01904149
Last Updated: 2016-04-01
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
606 participants
Primary outcome timeframe
over 8 hours after the first dose
Results posted on
2016-04-01
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 TRAM
Placebo single dose followed by Tramadol-multiple doses
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
152
|
151
|
150
|
51
|
51
|
51
|
|
Overall Study
Single-dose Phase
|
152
|
151
|
150
|
51
|
51
|
51
|
|
Overall Study
Multiple-dose Phase
|
150
|
146
|
149
|
48
|
48
|
49
|
|
Overall Study
COMPLETED
|
147
|
140
|
148
|
47
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
2
|
4
|
5
|
3
|
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 TRAM
Placebo single dose followed by Tramadol-multiple doses
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
0
|
1
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
1
|
3
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
non compliance with study drug
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Baseline characteristics by cohort
| Measure |
DKP/TRAM Followed by DKP/TRAM
n=152 Participants
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
|
DKP Followed by DKP
n=151 Participants
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
|
TRAM Followed by TRAM
n=150 Participants
Tramadol-single dose followed by Tramadol-multiple doses
|
Placebo Followed by DKP/TRAM
n=51 Participants
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
|
Placebo Followed by DKP
n=51 Participants
Placebo single dose followed by Dexketoprofen-multiple doses
|
Placebo Followed by TRAM
n=51 Participants
Placebo single dose followed by Tramadol-multiple doses
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 6.70 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 6.82 • n=4 Participants
|
47.4 years
STANDARD_DEVIATION 7.46 • n=21 Participants
|
47.2 years
STANDARD_DEVIATION 4.60 • n=8 Participants
|
47.6 years
STANDARD_DEVIATION 6.75 • n=8 Participants
|
|
Sex/Gender, Customized
Females
|
152 participants
n=5 Participants
|
151 participants
n=7 Participants
|
150 participants
n=5 Participants
|
51 participants
n=4 Participants
|
51 participants
n=21 Participants
|
51 participants
n=8 Participants
|
606 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
152 participants
n=5 Participants
|
151 participants
n=7 Participants
|
150 participants
n=5 Participants
|
51 participants
n=4 Participants
|
51 participants
n=21 Participants
|
51 participants
n=8 Participants
|
606 participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
26 participants
n=5 Participants
|
8 participants
n=4 Participants
|
7 participants
n=21 Participants
|
7 participants
n=8 Participants
|
89 participants
n=8 Participants
|
|
Region of Enrollment
Slovakia
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=8 Participants
|
39 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
63 participants
n=5 Participants
|
53 participants
n=7 Participants
|
60 participants
n=5 Participants
|
18 participants
n=4 Participants
|
23 participants
n=21 Participants
|
17 participants
n=8 Participants
|
234 participants
n=8 Participants
|
|
Region of Enrollment
Romania
|
32 participants
n=5 Participants
|
40 participants
n=7 Participants
|
32 participants
n=5 Participants
|
10 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=8 Participants
|
138 participants
n=8 Participants
|
|
Region of Enrollment
Lithuania
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
14 participants
n=8 Participants
|
|
Region of Enrollment
Russian Federation
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
15 participants
n=8 Participants
|
|
Region of Enrollment
Latvia
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=8 Participants
|
72 participants
n=8 Participants
|
|
Weight
|
75.2 kg
STANDARD_DEVIATION 15.15 • n=5 Participants
|
72.1 kg
STANDARD_DEVIATION 13.54 • n=7 Participants
|
71.3 kg
STANDARD_DEVIATION 12.17 • n=5 Participants
|
73.6 kg
STANDARD_DEVIATION 13.74 • n=4 Participants
|
72.9 kg
STANDARD_DEVIATION 14.60 • n=21 Participants
|
72.6 kg
STANDARD_DEVIATION 10.97 • n=8 Participants
|
72.9 kg
STANDARD_DEVIATION 13.58 • n=8 Participants
|
|
Height
|
163.9 cm
STANDARD_DEVIATION 5.40 • n=5 Participants
|
163.7 cm
STANDARD_DEVIATION 6.37 • n=7 Participants
|
164.1 cm
STANDARD_DEVIATION 6.10 • n=5 Participants
|
164.5 cm
STANDARD_DEVIATION 6.17 • n=4 Participants
|
163.5 cm
STANDARD_DEVIATION 5.94 • n=21 Participants
|
164.4 cm
STANDARD_DEVIATION 5.59 • n=8 Participants
|
164.0 cm
STANDARD_DEVIATION 5.94 • n=8 Participants
|
PRIMARY outcome
Timeframe: over 8 hours after the first dosePopulation: ITT population
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.
Outcome measures
| Measure |
DKP/TRAM
n=152 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
|
DEXKETOPROFEN
n=151 Participants
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
|
TRAMADOL
n=150 Participants
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
|
PLACEBO
n=153 Participants
Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
|
|---|---|---|---|---|
|
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
|
241.8 units on a scale
Standard Deviation 139.06
|
184.5 units on a scale
Standard Deviation 139.23
|
157.3 units on a scale
Standard Deviation 150.89
|
117.0 units on a scale
Standard Deviation 121.80
|
SECONDARY outcome
Timeframe: over 8 hours after first dosePopulation: ITT population
Percentage 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=152 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
|
DEXKETOPROFEN
n=151 Participants
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
|
TRAMADOL
n=150 Participants
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
|
PLACEBO
n=153 Participants
Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
|
|---|---|---|---|---|
|
Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
|
65.8 percentage of participants
|
47.7 percentage of participants
|
44.0 percentage of participants
|
30.7 percentage of participants
|
SECONDARY outcome
Timeframe: over 48 hours of the multiple-dose phasePopulation: ITT population
Sum 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=203 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
|
DEXKETOPROFEN
n=202 Participants
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
|
TRAMADOL
n=201 Participants
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
|
PLACEBO
Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
|
|---|---|---|---|---|
|
SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
|
2273.0 units on a scale
Standard Deviation 864.03
|
1965.2 units on a scale
Standard Deviation 912.19
|
2035.0 units on a scale
Standard Deviation 919.49
|
—
|
SECONDARY outcome
Timeframe: over 48 hours of the multiple-dose phasePopulation: ITT population
Percentage 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=203 Participants
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
|
DEXKETOPROFEN
n=202 Participants
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
|
TRAMADOL
n=201 Participants
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
|
PLACEBO
Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
|
|---|---|---|---|---|
|
Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)
|
94.1 percentage of participants
|
82.7 percentage of participants
|
88.6 percentage of participants
|
—
|
Adverse Events
DKP/TRAM Followed by DKP/TRAM
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
DKP Followed by DKP
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
TRAM Followed by TRAM
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo Followed by DKP/TRAM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Followed by DKP
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Followed by TRAM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DKP/TRAM Followed by DKP/TRAM
n=151 participants at risk
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
|
DKP Followed by DKP
n=152 participants at risk
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
|
TRAM Followed by TRAM
n=150 participants at risk
Tramadol-single dose followed by Tramadol-multiple doses
|
Placebo Followed by DKP/TRAM
n=52 participants at risk
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
|
Placebo Followed by DKP
n=50 participants at risk
Placebo single dose followed by Dexketoprofen-multiple doses
|
Placebo Followed by TRAM
n=51 participants at risk
Placebo single dose followed by Tramadol-multiple doses
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.66%
1/152 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
Abdominal wound dehiscense
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
abdominal pain lower
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
diarrhoea
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
peritoneal haematoma
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
pneumonia
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
postoperative wound infection
|
0.00%
0/151 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.66%
1/152 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Reproductive system and breast disorders
Fallopian tube torsion
|
0.00%
0/151 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.67%
1/150 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.00%
0/151 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.67%
1/150 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
Laparotomy
|
0.00%
0/151 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.67%
1/150 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
Pyrexia
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/150 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Reproductive system and breast disorders
Endometrial cancer stage I
|
0.00%
0/151 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/152 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
0.67%
1/150 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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=151 participants at risk
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
|
DKP Followed by DKP
n=152 participants at risk
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
|
TRAM Followed by TRAM
n=150 participants at risk
Tramadol-single dose followed by Tramadol-multiple doses
|
Placebo Followed by DKP/TRAM
n=52 participants at risk
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
|
Placebo Followed by DKP
n=50 participants at risk
Placebo single dose followed by Dexketoprofen-multiple doses
|
Placebo Followed by TRAM
n=51 participants at risk
Placebo single dose followed by Tramadol-multiple doses
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
9/151 • Number of events 10 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
3.9%
6/152 • Number of events 7 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
9.3%
14/150 • Number of events 15 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.8%
3/52 • Number of events 3 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
4.0%
2/50 • Number of events 2 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
9.8%
5/51 • Number of events 6 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
Vomiting
|
3.3%
5/151 • Number of events 5 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
3.9%
6/152 • Number of events 6 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.3%
8/150 • Number of events 8 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/50 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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
Constipation
|
4.0%
6/151 • Number of events 6 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
1.3%
2/152 • Number of events 2 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
4.0%
6/150 • Number of events 6 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
4.0%
2/50 • Number of events 2 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.9%
3/51 • Number of events 3 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Investigations
Platelet count increased
|
2.0%
3/151 • Number of events 3 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.3%
8/152 • Number of events 8 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
6.0%
9/150 • Number of events 9 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
6.0%
3/50 • Number of events 3 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
5.9%
3/51 • Number of events 3 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.66%
1/151 • Number of events 1 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
1.3%
2/152 • Number of events 2 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
1.3%
2/150 • Number of events 2 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/52 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.
|
6.0%
3/50 • Number of events 3 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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%
0/51 • Study duration for patients was up to 6 weeks
Analyzed for the Safety population (all patients randomized 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