At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 654 enrolled
Drug / intervention
Tramadol Hydrochloride/Dexketoprofen Trometamol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Tramadol Hydrochloride/Dexketoprofen Trometamol, Tramadol Hydrochloride/Paracetamol, and 1 other intervention for Acute Pain. Completed, enrolled 654 participants across 18 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesHungary, Italy, Poland, Spain, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedMay 2016
Primary CompletionFeb 2017
TodayJul 2026
First PostedMay 19, 2016
Enrollment StartApr 1, 2016
Primary CompletionFeb 14, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.1 years ago
Interventions
Tramadol Hydrochloride/Dexketoprofen Trometamoldrug
Tramadol Hydrochloride/Paracetamoldrug
Placebodrug