drugset / Trial / NCT02982161
Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib).
RandomizedParallel-groupTriple-blindTreatment
Summary
The MR308-3501 study is a multicenter, randomised, double-blind, parallel-group study in male and female adult subjects to demonstrate the efficacy of MR308 in the treatment of acute moderate to severe pain after the extraction of at least two third molars requiring bone removal.
Timeline
- Start
- 2016-12-28
- Primary completion
- 2018-01-04
- Completion
- 2018-01-04
Publications
- Viscusi ER, Langford R, Morte A, Vaque A, Cebrecos J, Sust M, Gimenez-Arnau JM, de Leon-Casasola O. Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials. Pain Ther. 2024 Dec;13(6):1617-1631. doi: 10.1007/s40122-024-00655-w. Epub 2024 Sep 24.
- Langford R, Pogatzki-Zahn EM, Morte A, Sust M, Cebrecos J, Vaque A, Ortiz E, Fettiplace J, Adeyemi S, Lopez-Cedrun JL, Bescos S, Gascon N, Plata-Salaman C. Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1). Adv Ther. 2024 Mar;41(3):1025-1045. doi: 10.1007/s12325-023-02744-2. Epub 2024 Jan 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Celecoxib | Other / unclassified | 100 mg | Oral |
| Comparator | Celecoxib | Other / unclassified | 150 mg | Oral |
| Comparator | Celecoxib | Other / unclassified | 200 mg | Oral |
| Comparator | Tramadol | Other / unclassified | 100 mg | Oral |
Indications
No indication recorded.