Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
- Conditions
- Acute Pain
- Interventions
- Registration Number
- NCT02777970
- Lead Sponsor
- Menarini Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 654
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tramadol/Dexketoprofen Placebo Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose; Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose. Tramadol/Paracetamol Placebo Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose; Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose. . Placebo Placebo Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose; Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose. Tramadol/Paracetamol Tramadol Hydrochloride/Paracetamol Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose; Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose. . Tramadol/Dexketoprofen Tramadol Hydrochloride/Dexketoprofen Trometamol Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose; Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x \[37.5mg/325mg\] film-coated tablets, oral single dose.
- Primary Outcome Measures
Name Time Method TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose) 6 hours post-dose TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6).
The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.
- Secondary Outcome Measures
Name Time Method % of Patients Achieving 50% of Max TOTPAR 8 hours post-dose Percentage of patients who achieved at least 50% of the maximum TOTPAR at 8 hours. In the present trial the achievable TOTPAR over 8 hours ranges between 0 and 32."
% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose 8 hours post-dose Percentage of patients who achieve at least 30% of PI Reduction versus baseline Over 8 Hours Post-dose. Percentage change of PI is calculated using the baseline value minus the PI assessed at 8 hours post-dose divided for the baseline value, then multiplied for 100.
Time to Confirmed FPPAR (First Perceptible Pain Relief) 2 hours post-dose Time to confirmed FPPAR (time to onset of analgesia) - i.e. time to FPPAR if confirmed by experiencing Meaningful Pain Relief (MPAR)
FPPAR and MPAR assessed by using stopwatches:
1. 'first perceptible' PAR (FPPAR), i.e, at the moment they first felt any PAR whatsoever;
2. 'meaningful' PAR (MPAR, ie, when the relief from pain became meaningful to them)% of Patients Requiring RM (Rescue Medication) 8 hours post-dose Percentage of patients who required RM within the first over 8 hours post-dose.
PGE (Patient Global Evaluation) 8 hours postdose PGE of the study medication (measured according to a five-point VRS from 1 = poor to 5 = excellent) at 8 hours post-dose or whenever the patient uses Rescue Medication (RM).
Trial Locations
- Locations (18)
Ars-Dent
🇵🇱Bialystok, Poland
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Birmingham Community Healthcare NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Hospital Médico Quirúrgico de Conxo
🇪🇸La Coruna, Spain
Dr. Tóth Bagi Zoltán Fogászati Rendeloje
🇭🇺Budapest, Hungary
Ospedale Civile San Salvatore di L'Aquila
🇮🇹L'Aquila, Italy
OralMed Studio Fogászati és Szájsebészeti Kft.
🇭🇺Budapest, Hungary
Universidad de Valencia
🇪🇸Valencia, Spain
Szegedi Tudományegyetem
🇭🇺Szeged, Hungary
Charme Clinique Klinika Stomatologii
🇵🇱Warszawa, Poland
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Azienda Ospedaliera Universitaria Integrata
🇮🇹Verona, Italy
University of Manchester
🇬🇧Manchester, United Kingdom
Centro Medico Teknon
🇪🇸Barcelona, Spain
Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic
🇵🇱Warszawa, Poland
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke on Trent, United Kingdom