SEGLENTIS was evaluated in a
Phase 3 clinical trial

Study design: SEGLENTIS in acute pain after bunionectomy and osteotomy1

The efficacy and safety of SEGLENTIS were evaluated in a pivotal, Phase 3, randomized, double-blind, parallel-group study comparing SEGLENTIS to tramadol hydrochloride, celecoxib, and placebo (NCT03108482).1

Study details1:

Efficacy and safety of SEGLENTIS clinical trial chart

IV, intravenously; NPRS, Numeric Pain Rating Scale; PO, orally; Q6H, every 6 hours; Q12H, every 12 hours; SPID48, summed pain intensity difference over 48 hours.

Total daily dose: 400 mg of SEGLENTIS (2x 56-mg celecoxib/44-mg tramadol hydrochloride tablets, twice a day), 200 mg of tramadol hydrochloride (50 mg 4 times a day), 200 mg of celecoxib (100 mg twice a day), or placebo 4 times a day.

The Phase 3 factorial study compared lower doses of tramadol and celecoxib than are optimal for treatment of acute pain, and this study is not suitable for making comparative efficacy claims.

See how, in a clinical study, SEGLENTIS managed acute pain in appropriate patients1

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References

  1. SEGLENTIS [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021.
  2. Viscusi ER, de Leon-Casasola O, Cebrecos J, et al. Celecoxib‐tramadol co‐crystal in patients with moderate‐to‐severe pain following bunionectomy with osteotomy: a phase 3, randomized, double‐blind, factorial, active‐ and placebo‐controlled trial. Pain Pract. 2022;00:1-15. doi:10.1111/papr.13136.