Clinical trial NCT02777970: Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Official title: Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: Acute pain
Acute moderate to severe pain
Postoperative pain
Dexketoprofen Tramadol
Dexketoprofen trometamol
Tramadol hydrochloride
Multimodal analgesia
Third molar extraction
Fixed drug combination
Paracetamol
Analgesics
Lead sponsor: Menarini Group
Sponsor class: INDUSTRY
First posted: 2016-05-19
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

Detailed description: The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.

In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio:

* TRAM.HCL/DKP.TRIS
* Paracetamol/TRAM.HCL
* Placebo.

Eligibility criteria: Inclusion Criteria:

* Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
* Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
* Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).

Exclusion Criteria:

* History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
* History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
* History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
* Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.

Primary outcomes:
measure: TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)
timeFrame: 6 hours post-dose
Secondary outcomes:
measure: % of Patients Achieving 50% of Max TOTPAR
timeFrame: 8 hours post-dose
measure: % of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose
timeFrame: 8 hours post-dose
measure: Time to Confirmed FPPAR (First Perceptible Pain Relief)
timeFrame: 2 hours post-dose
measure: % of Patients Requiring RM (Rescue Medication)
timeFrame: 8 hours post-dose
measure: PGE (Patient Global Evaluation)
timeFrame: 8 hours postdose
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Dr. Tóth Bagi Zoltán Fogászati Rendeloje
city: Budapest
country: Hungary
facility: OralMed Studio Fogászati és Szájsebészeti Kft.
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
city: L'Aquila
country: Italy
facility: Ospedale Civile San Salvatore di L'Aquila
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
city: Bialystok
country: Poland
facility: Ars-Dent
city: Warszawa
country: Poland
facility: Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic
city: Warszawa
country: Poland
facility: Charme Clinique Klinika Stomatologii
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: La Coruna
country: Spain
facility: Hospital Médico Quirúrgico de Conxo
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Universidad de Valencia
city: Birmingham
country: United Kingdom
facility: Birmingham Community Healthcare NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Manchester
country: United Kingdom
facility: University of Manchester
city: Stoke on Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References:
citation: Gay-Escoda C, Hanna M, Montero A, Dietrich T, Milleri S, Giergiel E, Zoltan TB, Varrassi G. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open. 2019 Feb 19;9(2):e023715. doi: 10.1136/bmjopen-2018-023715.