drugset / Trial / NCT03714672

Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction

NCT03714672

Phase 3 Completed 1151 enrolled Grünenthal GmbH Grünenthal, S.A. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluated a new drug fixed-dose combination tablet (FDC) called tramadol/diclofenac at two different strengths (fixed doses of 25 milligrams \[mg\] of tramadol and of diclofenac or of 50 mg each). Tramadol and diclofenac each relieve pain, but they do so by different mechanisms. They were used alone as comparator drug in this study. Both are marketed drugs and are standard treatment for acute pain, including wisdom tooth removal.

Timeline

Start
2017-08-26
Primary completion
2018-03-09
Completion
2018-03-22

Publications

  • Background Gay Escoda C, Piñera Penalva M, Velasco Vivancos V, Berini Aytés L. Cordales incluidos. Patología, clínica y tratamiento del tercer molar incluído. In: Gay Escoda C, Berini Aytés L. (eds.). Tratado de Cirugía Bucal. Tomo I. Madrid: Ergón; 2004. p. 355-85

Drugs

EvaluationDrugModalityDoseRoute
Subject Diclofenac Other / unclassified 25 mg
Subject Diclofenac Other / unclassified 50 mg
Subject Tramadol Other / unclassified 25 mg
Subject Tramadol Other / unclassified 50 mg

Indications

No indication recorded.