Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Study Location:

The School of Dentistry, College of Medical and Dental Sciences, University of Birmingham
Birmingham
England
B4 6 NN


Skip to Main Content

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

Completed

Open to: All Genders

Age: 18 Years - 70 Years

Medical Conditions

Pain


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity. DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2011

Oct 2011

Interventional

Intervention Type : Drug
Intervention Description : Dexketoprofen Trometamol low dose, oral film-coated table, once

Intervention Arm Group : DKP-TRIS low dose

Intervention Type : Drug
Intervention Description : Dexketoprofen Trometamol high dose, oral film-coated table, once

Intervention Arm Group : DKP-TRIS high dose

Intervention Type : Drug
Intervention Description : Tramadol Hydrochloride low dose, oral film-coated table, once

Intervention Arm Group : TRAM.HCl low dose

Intervention Type : Drug
Intervention Description : Tramadol Hydrochloride high dose, oral film-coated table, once

Intervention Arm Group : TRAM.HCl high dose

Intervention Type : Drug
Intervention Description : Ibuprofen 400 mg, oral film-coated table, once

Intervention Arm Group : Ibuprofen

Intervention Type : Drug
Intervention Description : Placebo, oral film-coated table, once

Intervention Arm Group : Placebo

Intervention Type : Drug
Intervention Description : DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once

Intervention Arm Group : DKP-TRIS low dose - TRAM.HCl low dose

Intervention Type : Drug
Intervention Description : DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once

Intervention Arm Group : DKP-TRIS low dose - TRAM.HCl high dose

Intervention Type : Drug
Intervention Description : DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once

Intervention Arm Group : DKP-TRIS high dose - TRAM.HCl low dose

Intervention Type : Drug
Intervention Description : DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once

Intervention Arm Group : DKP-TRIS high dose - TRAM.HCl high dose

You can take part if:


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.




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The School of Dentistry, College of Medical and Dental Sciences, University of Birmingham
    Birmingham
    England
    B4 6 NN
  • University Dental School Manchester
    Manchester
    England
    M15 6FH
  • University Dental Hospital
    Cardiff
    Wales
    CF14 4 XY


The study is sponsored by Menarini Group and funded by PRA Health Sciences .



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details

for Trial ID: NCT01307020

Last updated

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.