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 International

Information provided by (Responsible Party):

Menarini Group

ClinicalTrials.gov Identifier:

NCT01307020

First received: February 28, 2011

Last updated: November 12, 2012

Last verified: November 2012

History of Changes

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. From the 745 patients were enrolled (screened), 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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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
Number of Participants [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

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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 ]

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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 ]

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

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.

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

No publications provided

Responsible Party:	Menarini Group
ClinicalTrials.gov Identifier:	NCT01307020 History of Changes
Other Study ID Numbers:	DEX-TRA 02, 2010-022798-32
Study First Received:	February 28, 2011
Results First Received:	October 11, 2012
Last Updated:	November 12, 2012
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

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