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Trial record 3 of 7 for:    TRAMADOL | ( Map: Germany )

Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain (DEX-TRA 02)

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ClinicalTrials.gov Identifier: NCT01307020
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 10, 2012
Last Update Posted : August 12, 2013
Sponsor:
Collaborator:
PRA Health Sciences
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 Pain
Interventions Drug: Dexketoprofen Trometamol
Drug: Tramadol Hydrochloride
Drug: Ibuprofen
Drug: Placebo
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
Enrollment 745
Recruitment Details First patient in (screening) 23 Feb 2011, last patient out 14 Oct 2011. At 16 study centres in 6 European countries (Germany, Italy, Hungary, Poland, Spain and United Kingdom).
Pre-assignment Details The trial encompassed 3 visits: 1-Screening; 2-Dental surgery (patients who have moderate to severe pain afterwards were randomised and received study drug); 3-End of study. Overall, 745 patients were enrolled (screened), of them 611 were randomized to receive the study drug and therefore considered as started.
Arm/Group Title DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Hide Arm/Group Description DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once DKP-TRIS 12.5mg oral film-coated tablet, once DKP-TRIS 25mg oral film-coated tablet, once TRAM.HCl 37.5mg oral film-coated tablet, once TRAM.HCl 75mg oral film-coated tablet, once Ibuprofen 400mg oral film-coated tablet, once Placebo oral film-coated tablet, once
Period Title: Overall Study
Started 61 63 63 61 60 61 59 60 61 62
Safety Population 61 63 63 61 60 61 59 60 61 62
ITT (>= 1 Assessment Post Randomization) 60 62 63 61 60 60 59 59 60 62
Completed 61 62 62 60 60 61 58 60 61 62
Not Completed 0 1 1 1 0 0 1 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             1             1             0             0             1             0             0             0
Electronic data capture failure             0             1             0             0             0             0             0             0             0             0
Arm/Group Title DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo Total
Hide Arm/Group Description DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once DKP-TRIS 12.5mg oral film-coated tablet, once DKP-TRIS 25mg oral film-coated tablet, once TRAM.HCl 37.5mg oral film-coated tablet, once TRAM.HCl 75mg oral film-coated tablet, once Ibuprofen 400mg oral film-coated tablet, once Placebo oral film-coated tablet, once Total of all reporting groups
Overall Number of Baseline Participants 61 63 63 61 60 61 59 60 61 62 611
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 63 participants 63 participants 61 participants 60 participants 61 participants 59 participants 60 participants 61 participants 62 participants 611 participants
28.6  (7.64) 26.9  (7.62) 26.3  (7.33) 27.3  (7.55) 27.0  (9.85) 26.9  (6.94) 25.5  (7.15) 27.8  (7.99) 26.6  (6.48) 26.1  (6.64) 26.9  (7.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 63 participants 61 participants 60 participants 61 participants 59 participants 60 participants 61 participants 62 participants 611 participants
Female
35
  57.4%
39
  61.9%
36
  57.1%
34
  55.7%
36
  60.0%
44
  72.1%
38
  64.4%
28
  46.7%
41
  67.2%
33
  53.2%
364
  59.6%
Male
26
  42.6%
24
  38.1%
27
  42.9%
27
  44.3%
24
  40.0%
17
  27.9%
21
  35.6%
32
  53.3%
20
  32.8%
29
  46.8%
247
  40.4%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 61 participants 63 participants 63 participants 61 participants 60 participants 61 participants 59 participants 60 participants 61 participants 62 participants 611 participants
23.7  (3.39) 24.1  (3.69) 23.0  (2.87) 23.2  (3.19) 23.6  (3.20) 23.5  (3.30) 23.0  (3.19) 24.2  (3.08) 22.4  (3.04) 22.7  (2.80) 23.3  (3.21)
[1]
Measure Description: Body Mass Index (measured in kg/m^2)
1.Primary Outcome
Title Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.
Hide Description Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment
Arm/Group Title DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Hide Arm/Group Description:
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 12.5mg oral film-coated tablet, once
DKP-TRIS 25mg oral film-coated tablet, once
TRAM.HCl 37.5mg oral film-coated tablet, once
TRAM.HCl 75mg oral film-coated tablet, once
Ibuprofen 400mg oral film-coated tablet, once
Placebo oral film-coated tablet, once
Overall Number of Participants Analyzed 60 62 63 61 60 60 59 59 60 62
Measure Type: Number
Unit of Measure: percentage of patients
36.7 59.7 55.6 72.1 26.7 55.0 10.2 25.4 45.0 9.7
2.Secondary Outcome
Title Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.
Hide Description Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %
Time Frame 4, 8 and 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment
Arm/Group Title DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Hide Arm/Group Description:
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 12.5mg oral film-coated tablet, once
DKP-TRIS 25mg oral film-coated tablet, once
TRAM.HCl 37.5mg oral film-coated tablet, once
TRAM.HCl 75mg oral film-coated tablet, once
Ibuprofen 400mg oral film-coated tablet, once
Placebo oral film-coated tablet, once
Overall Number of Participants Analyzed 60 62 63 61 60 60 59 59 60 62
Measure Type: Number
Unit of Measure: percentage of patient
at 4 hours post-dose 63.3 72.6 65.1 78.7 40.0 65.0 11.9 23.7 56.7 6.5
at 8 hours post-dose 21.7 48.4 44.4 54.1 16.7 31.7 6.8 20.3 33.3 6.5
at 12 hours post-dose 11.7 35.5 28.6 37.7 10.0 13.3 5.1 15.3 25.0 6.5
3.Secondary Outcome
Title Percentage of Patients Using Rescue Medication at 6 Hours
Hide Description Percentage of patients using rescue medication at 6 hours post-dosing.
Time Frame Baseline to 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment
Arm/Group Title DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Hide Arm/Group Description:
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 12.5mg oral film-coated tablet, once
DKP-TRIS 25mg oral film-coated tablet, once
TRAM.HCl 37.5mg oral film-coated tablet, once
TRAM.HCl 75mg oral film-coated tablet, once
Ibuprofen 400mg oral film-coated tablet, once
Placebo oral film-coated tablet, once
Overall Number of Participants Analyzed 60 62 63 61 60 60 59 59 60 62
Measure Type: Number
Unit of Measure: percentage of patients
66.7 46.8 39.7 37.7 65.0 53.3 69.5 64.4 48.3 72.6
Time Frame 10 ± 3 days
Adverse Event Reporting Description Analyzed for the Safety population (all patients who received study treatment)
 
Arm/Group Title DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Hide Arm/Group Description DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once DKP-TRIS 12.5mg oral film-coated tablet, once DKP-TRIS 25mg oral film-coated tablet, once TRAM.HCl 37.5mg oral film-coated tablet, once TRAM.HCl 75mg oral film-coated tablet, once Ibuprofen 400mg oral film-coated tablet, once Placebo oral film-coated tablet, once
All-Cause Mortality
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   0/61 (0.00%)      0/63 (0.00%)      0/63 (0.00%)      0/61 (0.00%)      0/60 (0.00%)      0/61 (0.00%)      0/59 (0.00%)      1/60 (1.67%)      0/61 (0.00%)      0/62 (0.00%)    
Nervous system disorders                     
Dizziness * 1  0/61 (0.00%)  0 0/63 (0.00%)  0 0/63 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 1/60 (1.67%)  1 0/61 (0.00%)  0 0/62 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 12.5mg DKP-TRIS 25mg TRAM.HCl 37.5mg TRAM.HCl 75mg Ibuprofen 400mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   7/61 (11.48%)      9/63 (14.29%)      6/63 (9.52%)      10/61 (16.39%)      2/60 (3.33%)      4/61 (6.56%)      5/59 (8.47%)      14/60 (23.33%)      5/61 (8.20%)      1/62 (1.61%)    
Gastrointestinal disorders                     
Nausea * 1  4/61 (6.56%)  4 4/63 (6.35%)  4 1/63 (1.59%)  2 4/61 (6.56%)  4 2/60 (3.33%)  2 1/61 (1.64%)  1 1/59 (1.69%)  1 6/60 (10.00%)  7 0/61 (0.00%)  0 0/62 (0.00%)  0
Vomiting * 1  3/61 (4.92%)  4 4/63 (6.35%)  4 3/63 (4.76%)  3 5/61 (8.20%)  6 0/60 (0.00%)  0 2/61 (3.28%)  2 0/59 (0.00%)  0 5/60 (8.33%)  5 2/61 (3.28%)  2 0/62 (0.00%)  0
General disorders                     
Pyrexia * 1  3/61 (4.92%)  3 0/63 (0.00%)  0 0/63 (0.00%)  0 3/61 (4.92%)  3 0/60 (0.00%)  0 2/61 (3.28%)  2 1/59 (1.69%)  1 3/60 (5.00%)  3 1/61 (1.64%)  1 0/62 (0.00%)  0
Nervous system disorders                     
Dizziness * 1  1/61 (1.64%)  1 5/63 (7.94%)  5 1/63 (1.59%)  1 3/61 (4.92%)  3 0/60 (0.00%)  0 0/61 (0.00%)  0 2/59 (3.39%)  2 4/60 (6.67%)  4 2/61 (3.28%)  2 1/62 (1.61%)  1
Headache * 1  0/61 (0.00%)  0 1/63 (1.59%)  1 2/63 (3.17%)  2 0/61 (0.00%)  0 0/60 (0.00%)  0 0/61 (0.00%)  0 3/59 (5.08%)  3 2/60 (3.33%)  2 1/61 (1.64%)  1 0/62 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 13.1
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 investigator will allow the Sponsor at least 60 days time to review and comment upon the publication manuscript. It is agreed, that the results of the study will not be submitted for presentation, abstract, poster exhibition, or publication by the investigator until the Sponsor has reviewed/commented and agreed to any publication.
Results Point of Contact
Name/Title: Dr Angela Capriati, Corporate Clinical Research Director
Organization: Menarini Ricerche S.p.A.
Phone: +39 055 5680 9933
Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01307020     History of Changes
Other Study ID Numbers: DEX-TRA 02
2010-022798-32 ( EudraCT Number )
First Submitted: February 28, 2011
First Posted: March 2, 2011
Results First Submitted: October 11, 2012
Results First Posted: December 10, 2012
Last Update Posted: August 12, 2013