At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
In Brief
A Phase 2 clinical trial evaluating Dexketoprofen Trometamol, Tramadol Hydrochloride, and 3 other interventions for Pain. Completed, enrolled 745 participants across 16 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.
Study Details
Timeline
Interventions
Dexketoprofen Trometamol low dose, oral film-coated table, once
Dexketoprofen Trometamol high dose, oral film-coated table, once
Tramadol Hydrochloride low dose, oral film-coated table, once
Tramadol Hydrochloride high dose, oral film-coated table, once
Ibuprofen 400 mg, oral film-coated table, once
Placebo, oral film-coated table, once
DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once
DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once
DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once
DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once