Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar (DAVID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02777970|
Recruitment Status : Unknown
Verified February 2017 by Menarini Group.
Recruitment status was: Active, not recruiting
First Posted : May 19, 2016
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol Drug: Tramadol Hydrochloride/Paracetamol Drug: Placebo||Phase 4|
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:
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
One film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single-dose;
Two tablets of Placebo matching Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single-dose.
Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol
Active Comparator: Tramadol/Paracetamol
Two film-coated tablets of Tramadol Hydrochloride/Paracetamol 75 mg/650 mg [2 x 37.5mg/325mg] oral single dose;
One tablet of Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol oral single dose.
Drug: Tramadol Hydrochloride/Paracetamol
Placebo Comparator: Placebo
One tablet of Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Two tablets of Placebo matching Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
- TOTPAR6 (Total Pain Relief) [ Time Frame: 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).
- % of patients achieving 50% of max TOTPAR [ Time Frame: 8 hours post-dose ]Percentage of patients achieving at least 50% of maximum TOTPAR over 8 hours post-dose.
- % of patients achieving 30% of PI (Pain Intensity) reduction over 8 hours post-dose [ Time Frame: 8 hours post-dose ]Percentage of patients who achieved at least 30% of PI reduction versus baseline at each pre-specified time point over the 8-hour post-dose period.
- Time to confirmed FPPAR (First Perceptible Pain Relief) [ Time Frame: 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)
- % of patients requiring RM [ Time Frame: 8 hours post-dose ]Percentage of patients who required RM within the first over 8 hours post-dose.
- PGE (Patient Global Evaluation) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777970
|Dr. Tóth Bagi Zoltán Fogászati Rendeloje|
|Budapest, Hungary, 1052|
|OralMed Studio Fogászati és Szájsebészeti Kft.|
|Budapest, Hungary, 1126|
|Szeged, Hungary, 6725|
|Ospedale Civile San Salvatore di L'Aquila|
|L'Aquila, Italy, 67100|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Azienda Ospedaliero-Universitaria Pisana|
|Pisa, Italy, 56126|
|Azienda Ospedaliera Universitaria Integrata|
|Verona, Italy, 37134|
|Bialystok, Poland, 15-078|
|Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic|
|Warszawa, Poland, 00-852|
|Charme Clinique Klinika Stomatologii|
|Warszawa, Poland, 02-670|
|Centro Medico Teknon|
|Barcelona, Spain, 08022|
|Hospital Médico Quirúrgico de Conxo|
|La Coruna, Spain, 15702|
|Hospital Universitario Virgen del Rocío|
|Sevilla, Spain, 41009|
|Universidad de Valencia|
|Valencia, Spain, 46010|
|Birmingham Community Healthcare NHS Foundation Trust|
|Birmingham, United Kingdom, B4 6NN|
|University Hospital of Wales|
|Cardiff, United Kingdom, CF14 4XT|
|University of Manchester|
|Manchester, United Kingdom, M15 6FH|
|University Hospitals of North Midlands NHS Trust|
|Stoke on Trent, United Kingdom, ST4 6QG|