Celecoxib + tramadol


New Medicines

Acute moderate-to-severe pain


New formulation

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (filed)
Jan 20: In July 2019, FDA received the NDA for E-58425 from Esteve [5].


Fixed dose combination of anti-inflammatory drug celecoxib that inhibits cyclooxygenase 2 plus tramadol, a centrally acting weak synthetic μ-opioid receptor agonist and to a lesser extent δ- and κ-opioid receptors agonist.
A survey of 975 people in the UK reported that 21% experienced pain every day or on most days. 67% had visited their GP or a walk-in centre, requesting advice about pain relief [1].
Acute moderate-to-severe pain

Trial or other data

Apr 17: PIII STARDOM2 trial to demonstrate the safety and efficacy of celecoxib/tramadol, in the treatment of acute pain following abdominal hysterectomy surgery under general anaesthesia starts (NCT03062644). Efficacy will be assessed by establishing superiority of celecoxib/tramadol over placebo and non-inferiority as compared with tramadol, followed by superiority over tramadol based on the sum of pain intensity differences over a period of 0-4 hours. The trial will enrol approximately 1,100 female patients in Eastern & Western Europe, North America and Asia. Collection of primary outcome data due to complete Jun 18 [2,3].
Dec 16: PIII STARDOM1 trial to demonstrate the efficacy and safety of celecoxib/tramadol over-encapsulated tablet in the treatment of patient with acute moderate to severe pain after the extraction of at least two third molars requiring bone removal starts (NCT02982161). The study is enrolling approximately 765 patients in Hungary, Canada, France, Germany, Italy, Japan, Poland and Spain. Collection of primary outcome data due to complete Feb 18 [2,3].
Dec 17: PIII STARDOM1 has complete recruitment; STARDOM2 is still recruiting [3].
Jun 18: STARDOM2 trial completed 29th June 18, final recruitment 1138 patients [4].