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).
Richard LangfordAdelaida MorteMariano SustJesús CebrecosAnna VaquéEsther OrtizJames FettiplaceShola AdeyemiGrzegorz RabaLiudmila But-HusaimNeus GascónCarlos Plata-SalamánPublished in: European journal of pain (London, England) (2022)
In the randomized, double-blind, phase 3 STARDOM2 trial-in acute moderate-to-severe pain after abdominal hysterectomy-the novel co-crystal of tramadol-celecoxib (CTC) 200 mg BID was superior to placebo and non-inferior to tramadol 100 mg QID. Although superiority to tramadol was not reached, CTC 200 mg BID exposed patients to lower cumulative opioid (tramadol) doses than tramadol (100 mg QID) alone, with fewer treatment-emergent adverse events. CTC 200 mg thus has a clinically relevant improved benefit/risk profile compared with tramadol alone.
Keyphrases
- double blind
- phase iii
- placebo controlled
- chronic pain
- clinical trial
- circulating tumor cells
- pain management
- phase ii
- liver failure
- study protocol
- drug induced
- neuropathic pain
- end stage renal disease
- early onset
- circulating tumor
- ejection fraction
- respiratory failure
- postoperative pain
- aortic dissection
- randomized controlled trial
- hepatitis b virus
- spinal cord
- acute respiratory distress syndrome
- breast cancer risk