Acute Pain Clinical Trial
— DAVIDOfficial 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)
Verified date | March 2021 |
Source | Menarini Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Menarini Group |
Hungary, Italy, Poland, Spain, United Kingdom,
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 |
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