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

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

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Tramadol/Diclofenac 50/50: 9.9 (9.3 to 10.4) units on a scale NCT03714672 ↗

registry analysis (superiority test); Tramadol/Diclofenac 50/50 vs Diclofenac 50; p <0.0001; Mean Difference (Final Values) -4.1 (95% CI -4.8 to -3.4); ANCOVA NCT03714672 ↗

registry analysis (superiority test); Tramadol/Diclofenac 50/50 vs Tramadol 50; p <0.0001; Mean Difference (Final Values) -4.5 (95% CI -5.2 to -3.8); ANCOVA NCT03714672 ↗

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

Evaluation	Drug	Modality	Dose	Route
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.