drugset / Trial / NCT03714672
Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction
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
| 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.