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

This study has been completed.
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT01307020
First received: February 28, 2011
Last updated: July 31, 2013
Last verified: July 2013
Results First Received: October 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Dexketoprofen Trometamol
Drug: Tramadol Hydrochloride
Drug: Ibuprofen
Drug: Placebo
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 12.5mg DKP-TRIS 12.5mg oral film-coated tablet, once
DKP-TRIS 25mg DKP-TRIS 25mg oral film-coated tablet, once
TRAM.HCl 37.5mg TRAM.HCl 37.5mg oral film-coated tablet, once
TRAM.HCl 75mg TRAM.HCl 75mg oral film-coated tablet, once
Ibuprofen 400mg Ibuprofen 400mg oral film-coated tablet, once
Placebo Placebo oral film-coated tablet, once

Participant Flow:   Overall Study
    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
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 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DKP-TRIS 12.5mg - TRAM.HCl 37.5mg DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 12.5mg - TRAM.HCl 75mg DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 37.5mg DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
DKP-TRIS 25mg - TRAM.HCl 75mg DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
DKP-TRIS 12.5mg DKP-TRIS 12.5mg oral film-coated tablet, once
DKP-TRIS 25mg DKP-TRIS 25mg oral film-coated tablet, once
TRAM.HCl 37.5mg TRAM.HCl 37.5mg oral film-coated tablet, once
TRAM.HCl 75mg TRAM.HCl 75mg oral film-coated tablet, once
Ibuprofen 400mg Ibuprofen 400mg oral film-coated tablet, once
Placebo Placebo oral film-coated tablet, once
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 61   63   63   61   60   61   59   60   61   62   611 
Age 
[Units: Years]
Mean (Standard Deviation)
 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) 
Gender 
[Units: Participants]
                     
Female   35   39   36   34   36   44   38   28   41   33   364 
Male   26   24   27   27   24   17   21   32   20   29   247 
BMI [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 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] Body Mass Index (measured in kg/m^2)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.   [ Time Frame: 6 hours ]

2.  Secondary:   Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.   [ Time Frame: 4, 8 and 12 hours ]

3.  Secondary:   Percentage of Patients Using Rescue Medication at 6 Hours   [ Time Frame: Baseline to 6 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr Angela Capriati, Corporate Clinical Research Director
Organization: Menarini Ricerche S.p.A.
phone: +39 055 5680 9933
e-mail: acapriati@menarini-ricerche.it


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01307020     History of Changes
Other Study ID Numbers: DEX-TRA 02
2010-022798-32 ( EudraCT Number )
Study First Received: February 28, 2011
Results First Received: October 11, 2012
Last Updated: July 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Hungary: Research Ethics Medical Committee
Italy: Ethics Committee
Poland: Ministry of Health
Spain: Ministry of Health
United Kingdom: Research Ethics Committee