PainPhase 2DEX-TRA 02NCT01307020
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
A Phase 2 study testing Dexketoprofen Trometamol, Tramadol Hydrochloride and Ibuprofen in people with Pain, run by Menarini Group at 16 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Dexketoprofen Trometamol, Tramadol Hydrochloride and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 745 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Feb 2011to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Spain6 sites
Facultad de Odontología. Departamento de Cirugía Bucal y Maxilofacial, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL)
L'Hospitalet de Llobregat, Barcelona, 08907
Universidad Complutense de Madrid
Madrid, Madrid, 28040
Hospital Médico Quirúrgico de Conxo
Santiago de Compostela, A Coruña, 15706
Departamento de Estomatología, Facultad de Odontología. Universidad de Sevilla
Seville, Sevilla, 41009
Departament d'Estomatologia, Clínica Odontològica, Universidad de Valencia - Fundació Lluís Alcanyís
Valencia, Valencia, 046010
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
United Kingdom3 sites
The School of Dentistry, College of Medical and Dental Sciences, University of Birmingham
Birmingham, England, B4 6 NN
University Dental Hospital
Cardiff, Wales, CF14 4 XY
University Dental School Manchester
Manchester, England, M15 6FH
Germany2 sites
Klinik und Polickinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Italy2 sites
Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci
Pisa, Pisa, 56126
Centro di Ricerche Cliniche di Verona Srl. Policlinico G.B.Rossi
Verona, Verona, 37134
Poland2 sites
Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic
Warsaw, Masovian Voivodeship, 00-852
Dental Service spólka jawna
Warsaw, Masovian Voivodeship, 02-791
Hungary1 site
Dr Tóth Bagi Zoltán Fogászati Rendeloje
Budapest, Budapest, 1052
About this study
Official 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
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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen TrometamolDrug
Dexketoprofen Trometamol low dose, oral film-coated table, once
Dexketoprofen TrometamolDrug
Dexketoprofen Trometamol high dose, oral film-coated table, once
Tramadol HydrochlorideDrug
Tramadol Hydrochloride low dose, oral film-coated table, once
Tramadol HydrochlorideDrug
Tramadol Hydrochloride high dose, oral film-coated table, once
IbuprofenDrug
Ibuprofen 400 mg, oral film-coated table, once
PlaceboDrug
Placebo, oral film-coated table, once
Dexketoprofen Trometamol + Tramadol HydrochlorideDrug
DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once
Dexketoprofen Trometamol + Tramadol HydrochlorideDrug
DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once
Dexketoprofen Trometamol + Tramadol HydrochlorideDrug
DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once
Dexketoprofen Trometamol + Tramadol HydrochlorideDrug
DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
| TRAM.HCl high dose | Active comparator | Not described Receives: Drug: Tramadol Hydrochloride |
| TRAM.HCl low dose | Active comparator | Not described Receives: Drug: Tramadol Hydrochloride |
| DKP-TRIS high dose | Active comparator | Not described Receives: Drug: Dexketoprofen Trometamol |
| DKP-TRIS low dose | Active comparator | Not described Receives: Drug: Dexketoprofen Trometamol |
| DKP-TRIS low dose - TRAM.HCl low dose | Experimental | Not described Receives: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
| DKP-TRIS low dose - TRAM.HCl high dose | Experimental | Not described Receives: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
| DKP-TRIS high dose - TRAM.HCl low dose | Experimental | Not described Receives: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
| DKP-TRIS high dose - TRAM.HCl high dose | Experimental | Not described Receives: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.
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 %
Measured: 6 hours
Secondary outcomes (2)
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.
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 %
Measured: 4, 8 and 12 hours
Percentage of Patients Using Rescue Medication at 6 Hours
Percentage of patients using rescue medication at 6 hours post-dosing.
Measured: Baseline to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Cosme Gay-Escoda, Professor, Study chair, Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL) 08907 Hospitalet de Llobregat, Barcelona (Spain)R Andrew Moore, Professor, Study chair, Pain Research & Nuffield Division of Anaesthesics, Department of Clinical Neurosciences, University of Oxford. The Churchill, Oxford OX3 7LJ (United Kingdom)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307020
- Sponsor's protocol ID
- DEX-TRA 02
- Other IDs
- 2010-022798-32
- Acronym
- DEX-TRA 02
- Status last verified
- Jul 2013
- First submitted
- 28 Feb 2011
- Last updated
- 12 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Moore RA, Gay-Escoda C, Figueiredo R, Toth-Bagi Z, Dietrich T, Milleri S, Torres-Lagares D, Hill CM, Garcia-Garcia A, Coulthard P, Wojtowicz A, Matenko D, Penarrocha-Diago M, Cuadripani S, Piza-Vallespir B, Guerrero-Bayon C, Bertolotti M, Contini MP, Scartoni S, Nizzardo A, Capriati A, Maggi CA. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541. doi: 10.1186/s10194-015-0541-5. Epub 2015 Jun 27.
PubMed 26123824
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01307020
- Acronym / sponsor ID
- DEX-TRA 02 / DEX-TRA 02
- Conditions
- Pain
- Keywords
- Moderate to severe pain, Postoperative pain, Analgesics, Dexketoprofen, Tramadol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 745 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Posted 10 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Ibuprofen | Active comparator | Drug: Ibuprofen |
| TRAM.HCl high dose | Active comparator | Drug: Tramadol Hydrochloride |
| TRAM.HCl low dose | Active comparator | Drug: Tramadol Hydrochloride |
| DKP-TRIS high dose | Active comparator | Drug: Dexketoprofen Trometamol |
| DKP-TRIS low dose | Active comparator | Drug: Dexketoprofen Trometamol |
| DKP-TRIS low dose - TRAM.HCl low dose | Experimental | Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
| DKP-TRIS low dose - TRAM.HCl high dose | Experimental | Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
| DKP-TRIS high dose - TRAM.HCl low dose | Experimental | Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
| DKP-TRIS high dose - TRAM.HCl high dose | Experimental | Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexketoprofen TrometamolDexketoprofen Trometamol low dose, oral film-coated table, once | Drug | DKP-TRIS low dose |
| Dexketoprofen TrometamolDexketoprofen Trometamol high dose, oral film-coated table, once | Drug | DKP-TRIS high dose |
| Tramadol HydrochlorideTramadol Hydrochloride low dose, oral film-coated table, once | Drug | TRAM.HCl low dose |
| Tramadol HydrochlorideTramadol Hydrochloride high dose, oral film-coated table, once | Drug | TRAM.HCl high dose |
| IbuprofenIbuprofen 400 mg, oral film-coated table, once | Drug | Ibuprofen |
| PlaceboPlacebo, oral film-coated table, once | Drug | Placebo |
| Dexketoprofen Trometamol + Tramadol HydrochlorideDKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once | Drug | DKP-TRIS low dose - TRAM.HCl low dose |
| Dexketoprofen Trometamol + Tramadol HydrochlorideDKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once | Drug | DKP-TRIS low dose - TRAM.HCl high dose |
| Dexketoprofen Trometamol + Tramadol HydrochlorideDKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once | Drug | DKP-TRIS high dose - TRAM.HCl low dose |
| Dexketoprofen Trometamol + Tramadol HydrochlorideDKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once | Drug | DKP-TRIS high dose - TRAM.HCl high dose |
Primary outcome
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.
Time frame: 6 hours
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 %
2 secondary outcomes
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
Percentage of Patients Using Rescue Medication at 6 Hours
Time frame: Baseline to 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26123824Moore RA, Gay-Escoda C, Figueiredo R, Toth-Bagi Z, Dietrich T, Milleri S, Torres-Lagares D, Hill CM, Garcia-Garcia A, Coulthard P, Wojtowicz A, Matenko D, Penarrocha-Diago M, Cuadripani S, Piza-Vallespir B, Guerrero-Bayon C, Bertolotti M, Contini MP, Scartoni S, Nizzardo A, Capriati A, Maggi CA. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541. doi: 10.1186/s10194-015-0541-5. Epub 2015 Jun 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cosme Gay-Escoda, Professor study chair
Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL) 08907 Hospitalet de Llobregat, Barcelona (Spain)
R Andrew Moore, Professor study chair
Pain Research & Nuffield Division of Anaesthesics, Department of Clinical Neurosciences, University of Oxford. The Churchill, Oxford OX3 7LJ (United Kingdom)
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexketoprofen Trometamol, Tramadol Hydrochloride and Ibuprofen in people with Pain, run by Menarini Group at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, United Kingdom, Germany, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.