Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 451 for:    TRAMADOL

Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (DAVID lap)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904149
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Menarini Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acute Pain
Interventions Drug: Placebo
Drug: Dexketoprofen-single dose
Drug: Tramadol-single dose
Drug: Dexketoprofen/Tramadol-single dose
Drug: Dexketoprofen-multiple doses
Drug: Tramadol-multiple doses
Drug: Dexketoprofen/Tramadol-multiple doses
Enrollment 606
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DKP/TRAM Followed by DKP/TRAM DKP Followed by DKP TRAM Followed by TRAM Placebo Followed by DKP/TRAM Placebo Followed by DKP Placebo Followed by TRAM
Hide Arm/Group Description Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses Dexketoprofen-single dose followed by Dexketoprofen-multiple doses Tramadol-single dose followed by Tramadol-multiple doses Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Placebo single dose followed by Dexketoprofen-multiple doses Placebo single dose followed by Tramadol-multiple doses
Period Title: Overall Study
Started 152 151 150 51 51 51
Single-dose Phase 152 151 150 51 51 51
Multiple-dose Phase 150 146 149 48 48 49
Completed 147 140 148 47 46 48
Not Completed 5 11 2 4 5 3
Reason Not Completed
Adverse Event             3             4             0             1             1             2
Lack of Efficacy             0             3             1             3             3             1
Withdrawal by Subject             1             3             1             0             1             0
Protocol Violation             0             1             0             0             0             0
non compliance with study drug             1             0             0             0             0             0
Arm/Group Title DKP/TRAM Followed by DKP/TRAM DKP Followed by DKP TRAM Followed by TRAM Placebo Followed by DKP/TRAM Placebo Followed by DKP Placebo Followed by TRAM Total
Hide Arm/Group Description Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses Dexketoprofen-single dose followed by Dexketoprofen-multiple doses Tramadol-single dose followed by Tramadol-multiple doses Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Placebo single dose followed by Dexketoprofen-multiple doses Placebo single dose followed by Tramadol-multiple doses Total of all reporting groups
Overall Number of Baseline Participants 152 151 150 51 51 51 606
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) population (which includes all patients randomized).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 151 participants 150 participants 51 participants 51 participants 51 participants 606 participants
48.1  (6.70) 47.2  (7.07) 47.6  (6.87) 47.4  (6.82) 47.4  (7.46) 47.2  (4.60) 47.6  (6.75)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Females Number Analyzed 152 participants 151 participants 150 participants 51 participants 51 participants 51 participants 606 participants
152 151 150 51 51 51 606
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 152 participants 151 participants 150 participants 51 participants 51 participants 51 participants 606 participants
152 151 150 51 51 51 606
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 151 participants 150 participants 51 participants 51 participants 51 participants 606 participants
Hungary 22 19 26 8 7 7 89
Slovakia 7 13 8 5 2 4 39
Spain 1 2 1 0 0 1 5
Poland 63 53 60 18 23 17 234
Romania 32 40 32 10 12 12 138
Lithuania 2 4 3 1 1 3 14
Russian Federation 3 3 3 2 2 2 15
Latvia 22 17 17 7 4 5 72
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 152 participants 151 participants 150 participants 51 participants 51 participants 51 participants 606 participants
75.2  (15.15) 72.1  (13.54) 71.3  (12.17) 73.6  (13.74) 72.9  (14.60) 72.6  (10.97) 72.9  (13.58)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 152 participants 151 participants 150 participants 51 participants 51 participants 51 participants 606 participants
163.9  (5.40) 163.7  (6.37) 164.1  (6.10) 164.5  (6.17) 163.5  (5.94) 164.4  (5.59) 164.0  (5.94)
1.Primary Outcome
Title SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
Hide Description

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.

Time Frame over 8 hours after the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title DKP/TRAM DEXKETOPROFEN TRAMADOL PLACEBO
Hide Arm/Group Description:
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
Overall Number of Participants Analyzed 152 151 150 153
Mean (Standard Deviation)
Unit of Measure: units on a scale
241.8  (139.06) 184.5  (139.23) 157.3  (150.89) 117.0  (121.80)
2.Secondary Outcome
Title Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)
Hide Description

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.

Time Frame over 8 hours after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title DKP/TRAM DEXKETOPROFEN TRAMADOL PLACEBO
Hide Arm/Group Description:
Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)
Overall Number of Participants Analyzed 152 151 150 153
Measure Type: Number
Unit of Measure: percentage of participants
65.8 47.7 44.0 30.7
3.Secondary Outcome
Title SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)
Hide Description

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.

Time Frame over 48 hours of the multiple-dose phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title DKP/TRAM DEXKETOPROFEN TRAMADOL
Hide Arm/Group Description:
Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Overall Number of Participants Analyzed 203 202 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
2273.0  (864.03) 1965.2  (912.19) 2035.0  (919.49)
4.Secondary Outcome
Title Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)
Hide Description

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.

Time Frame over 48 hours of the multiple-dose phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title DKP/TRAM DEXKETOPROFEN TRAMADOL
Hide Arm/Group Description:
Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
Overall Number of Participants Analyzed 203 202 201
Measure Type: Number
Unit of Measure: percentage of participants
94.1 82.7 88.6
Time Frame Study duration for patients was up to 6 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title DKP/TRAM Followed by DKP/TRAM DKP Followed by DKP TRAM Followed by TRAM Placebo Followed by DKP/TRAM Placebo Followed by DKP Placebo Followed by TRAM
Hide Arm/Group Description Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses Dexketoprofen-single dose followed by Dexketoprofen-multiple doses Tramadol-single dose followed by Tramadol-multiple doses Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses Placebo single dose followed by Dexketoprofen-multiple doses Placebo single dose followed by Tramadol-multiple doses
All-Cause Mortality
DKP/TRAM Followed by DKP/TRAM DKP Followed by DKP TRAM Followed by TRAM Placebo Followed by DKP/TRAM Placebo Followed by DKP Placebo Followed by TRAM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DKP/TRAM Followed by DKP/TRAM DKP Followed by DKP TRAM Followed by TRAM Placebo Followed by DKP/TRAM Placebo Followed by DKP Placebo Followed by TRAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/151 (4.64%)      2/152 (1.32%)      1/150 (0.67%)      0/52 (0.00%)      0/50 (0.00%)      0/51 (0.00%)    
Gastrointestinal disorders             
abdominal pain lower * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
diarrhoea * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
peritoneal haematoma * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
General disorders             
Pyrexia * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Infections and infestations             
pneumonia * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
postoperative wound infection * 1  0/151 (0.00%)  0 1/152 (0.66%)  1 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Injury, poisoning and procedural complications             
Post procedural haemorrhage * 1  1/151 (0.66%)  1 1/152 (0.66%)  1 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Abdominal wound dehiscense * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Anaemia postoperative * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Psychiatric disorders             
Psychotic disorder * 1  1/151 (0.66%)  1 0/152 (0.00%)  0 0/150 (0.00%)  0 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Reproductive system and breast disorders             
Fallopian tube torsion * 1  0/151 (0.00%)  0 0/152 (0.00%)  0 1/150 (0.67%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Ovarian torsion * 1  0/151 (0.00%)  0 0/152 (0.00%)  0 1/150 (0.67%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Endometrial cancer stage I * 1 [1]  0/151 (0.00%)  0 0/152 (0.00%)  0 1/150 (0.67%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Surgical and medical procedures             
Laparotomy * 1  0/151 (0.00%)  0 0/152 (0.00%)  0 1/150 (0.67%)  1 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
[1]
The investigator assessed the event as non serious. However, the event seriousness was upgraded by the sponsor as "other medically important condition".
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DKP/TRAM Followed by DKP/TRAM DKP Followed by DKP TRAM Followed by TRAM Placebo Followed by DKP/TRAM Placebo Followed by DKP Placebo Followed by TRAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/151 (14.57%)      22/152 (14.47%)      33/150 (22.00%)      3/52 (5.77%)      10/50 (20.00%)      10/51 (19.61%)    
Gastrointestinal disorders             
Nausea * 1  9/151 (5.96%)  10 6/152 (3.95%)  7 14/150 (9.33%)  15 3/52 (5.77%)  3 2/50 (4.00%)  2 5/51 (9.80%)  6
Vomiting * 1  5/151 (3.31%)  5 6/152 (3.95%)  6 8/150 (5.33%)  8 0/52 (0.00%)  0 0/50 (0.00%)  0 0/51 (0.00%)  0
Constipation * 1  6/151 (3.97%)  6 2/152 (1.32%)  2 6/150 (4.00%)  6 0/52 (0.00%)  0 2/50 (4.00%)  2 3/51 (5.88%)  3
Investigations             
Platelet count increased * 1  3/151 (1.99%)  3 8/152 (5.26%)  8 9/150 (6.00%)  9 0/52 (0.00%)  0 3/50 (6.00%)  3 3/51 (5.88%)  3
Blood lactate dehydrogenase increased * 1  1/151 (0.66%)  1 2/152 (1.32%)  2 2/150 (1.33%)  2 0/52 (0.00%)  0 3/50 (6.00%)  3 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Angela Capriati, Corporate Director of Clinical Research
Organization: Menarini Ricerche S.p.A.
Phone: +3905556809933
EMail: ACapriati@menarini-ricerche.it
Layout table for additonal information
Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01904149     History of Changes
Other Study ID Numbers: DEX-TRA-04
2012-004545-32 ( EudraCT Number )
First Submitted: July 17, 2013
First Posted: July 22, 2013
Results First Submitted: February 9, 2015
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2016