drugset / Trial / NCT03062644
Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2.
RandomizedParallel-groupTriple-blindTreatment
Summary
The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).
Timeline
- Start
- 2017-04-05
- Primary completion
- 2018-06-29
- Completion
- 2018-06-29
Outcome
Missed primary endpoint
paper Although the study did not meet its primary endpoint, CTC 200 mg showed a clinically relevant improvement in overall benefit/risk profile versus tramadol alone PMID 35974668 ↗
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, Morte A, Sust M, Cebrecos J, Vaque A, Ortiz E, Fettiplace J, Adeyemi S, Raba G, But-Husaim L, Gascon N, Plata-Salaman C. Efficacy and safety of co-crystal of tramadol-celecoxib (CTC) in acute moderate-to-severe pain after abdominal hysterectomy: A randomized, double-blind, phase 3 trial (STARDOM2). Eur J Pain. 2022 Nov;26(10):2083-2096. doi: 10.1002/ejp.2021. Epub 2022 Sep 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 100 mg | Oral |
| Comparator | MR308 | Other / unclassified | 100 mg | Oral |
| Comparator | MR308 | Other / unclassified | 150 mg | Oral |
| Comparator | MR308 | Other / unclassified | 200 mg | Oral |
| Subject | Tramadol | Other / unclassified | 100 mg | Oral |
Indications
No indication recorded.