Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar

Acute Pain Clinical Trial

— DAVID  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777970
• Other study ID #: DEX-TRA-06
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: February 14, 2017

Study information

• Verified date: March 2021
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Tramadol Hydrochloride/Dexketoprofen Trometamol

• Tramadol Hydrochloride/Paracetamol

• Placebo

Locations

Country	Name	City	State
Hungary	Dr. Tóth Bagi Zoltán Fogászati Rendeloje	Budapest
Hungary	OralMed Studio Fogászati és Szájsebészeti Kft.	Budapest
Hungary	Szegedi Tudományegyetem	Szeged
Italy	Ospedale Civile San Salvatore di L'Aquila	L'Aquila
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Azienda Ospedaliera Universitaria Integrata	Verona
Poland	Ars-Dent	Bialystok
Poland	Charme Clinique Klinika Stomatologii	Warszawa
Poland	Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic	Warszawa
Spain	Centro Medico Teknon	Barcelona
Spain	Hospital Médico Quirúrgico de Conxo	La Coruna
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Universidad de Valencia	Valencia
United Kingdom	Birmingham Community Healthcare NHS Foundation Trust	Birmingham
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	University of Manchester	Manchester
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke on Trent

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Group

Countries where clinical trial is conducted

Hungary,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOTPAR6 (Total Pain Relief Over 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.	6 hours post-dose
Secondary	% of Patients Achieving 50% of Max TOTPAR	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."	8 hours post-dose
Secondary	% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 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.	8 hours post-dose
Secondary	Time to Confirmed FPPAR (First Perceptible Pain Relief)	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: 'first perceptible' PAR (FPPAR), i.e, at the moment they first felt any PAR whatsoever; 'meaningful' PAR (MPAR, ie, when the relief from pain became meaningful to them)	2 hours post-dose
Secondary	% of Patients Requiring RM (Rescue Medication)	Percentage of patients who required RM within the first over 8 hours post-dose.	8 hours post-dose
Secondary	PGE (Patient Global Evaluation)	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).	8 hours postdose