Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain

Phase 4 Completed 538 enrolled Menarini International Operations Luxembourg SA

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.

Timeline

Start: 2020-09-17
Primary completion: 2022-05-04
Completion: 2022-05-04

Publications

Varrassi G, Hanna M, Coaccioli S, Fabrizzi P, Baldini S, Kruljac I, Brotons C, Perrot S. Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE). Pain Ther. 2024 Aug;13(4):1007-1022. doi: 10.1007/s40122-024-00623-4. Epub 2024 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dexketoprofen	Small molecule	25 mg	Oral
Comparator	Tramadol	Other / unclassified	75 mg	Oral
Comparator	Tramadol	Other / unclassified	100 mg	Oral

Indications

No indication recorded.