Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01307020
• Date of registration: 28/02/2011
• Prospective Registration: No
• Primary sponsor: Menarini Group
• Public title: Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain DEX-TRA 02
• Scientific title: Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
• Date of first enrolment: February 2011
• Target sample size: 745
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01307020
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Germany, Hungary, Italy, Poland, Spain, United Kingdom

Contacts

• Name: R Andrew Moore, Professor
• Affiliation: Pain Research & Nuffield Division of Anaesthesics, Department of Clinical Neurosciences, University of Oxford. The Churchill, Oxford OX3 7LJ (United Kingdom)

• Name: Cosme Gay-Escoda, Professor
• Affiliation: Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL) 08907 Hospitalet de Llobregat, Barcelona (Spain)

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients meeting ALL the following criteria will be eligible for entry into the study:

- Male or female patients aged 18 to 70 years old. Females participating in the study
must be either: of non-childbearing potential, or willing to use a highly effective
contraceptive method.

- Scheduled for outpatient surgical extraction -under local anaesthesia- of third
mandibular molar teeth, with at least one of which is fully or partially impacted in
the mandible requiring bone manipulation.

- Normal physical examination or without clinically relevant abnormalities.

At randomisation (after surgery):

No intake of analgesics (including prescription and over the counter drugs) within 24h
prior to the surgery.

- No complication during the surgery, duration of surgery < 1 hour and not requiring
re-anaesthesia.

- Patients experiencing pain of moderate or higher intensity in the first four hours
after the end of surgery.

Exclusion Criteria:

- History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid.

- History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or
angioneurotic oedema.

- History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal
bleeding or other active bleedings.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Placebo

Drug: Tramadol Hydrochloride

Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride

Drug: Ibuprofen

Drug: Dexketoprofen Trometamol

Primary Outcome(s)

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

Secondary Outcome(s)

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

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]

Secondary ID(s)

DEX-TRA 02

2010-022798-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PRA Health Sciences

Results

• Results available: Yes
• Date Posted: 10/12/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01307020