A Phase 2 interventional study of Etoricoxib 60 mg and Placebo for Etoricoxib 60 mg in Pain, Osteoarthritis, Hip and Postoperative Pain, sponsored by University of Erlangen-Nürnberg Medical School. Terminated at 1 site in Germany. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-14.
Sponsored by University of Erlangen-Nürnberg Medical School · Phase 2, Interventional, and Treatment
The purpose of this study is to test the hypothesis that orally administered etoricoxib (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients and thus reduces pain and suffering.
This study will be a multiple centre, double-blind, placebo-controlled, randomized, parallel group study conducted in male and female adult patients undergoing elective primary single hip arthroplasty. In part 1 of the study 12 patients will be enrolled in the study and will be administrated 120 mg Etoricoxib or placebo orally on day one post surgery. The results from part 1 should help to adjust sampling time points (for blood, cerebrospinal fluid and hip drain fluid) if necessary. In part 2 of the study 40 patients will be enrolled and should receive 120 mg etoricoxib or placebo two hours before and 24 hours after surgery.
Primary end points will be the inflammatory mediators on peripheral and central levels. After surgical manipulation we expect increased mediators on both sides. It will be investigated if the medication could reduce the mediators compared to placebo and if the effect is related to pharmacokinetic parameters.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 23 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Study part 1 (n = 8)
Drug: Etoricoxib 60 mg
Study part 1 (n = 4)
Drug: Placebo for Etoricoxib 60 mg
Study part 2 (n = 20)
Drug: Etoricoxib 60 mg
Study part 2 (n = 20)
Drug: Placebo for Etoricoxib 60 mg
film coated tablet 60 mg (orally), 120 mg (= 2 tablets a 60 mg) once daily, on day one post surgery
Also known as: Arcoxia 60 mg, MK0663
film coated tablet (orally), two tablets once daily, on day one post surgery
Also known as: Matching Placebo
film coated tablet (orally), 120 mg (= 2 tablets a 60 mg) once daily, two hours before and 24 hours after surgery
Also known as: Arcoxia 60 mg, MK0663
film coated tablet (orally), 2 tablets once daily, two hours before and 24 hours after surgery
Also known as: Matching Placebo
To test the hypothesis that orally administered etoricoxib (COX-2 inhibitor) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients.
Time frame: within 24 hours post dosing (study part 1) and within 48 hour post dosing (study part 2)
To determine the CSF (cerebrospinal fluid), plasma and tissue pharmacokinetics of orally administered etoricoxib.
Time frame: within 24 hours post dosing (study part 1) and within 48 hours post dosing (study part 2)
To correlate the prostaglandin and cytokine response to clinical outcome parameters after hip arthroplasty.
Time frame: within 4 days post dosing (study part 1 and 2)
To assess the safety (via clinical laboratory tests and adverse events) of a single dose of 120 mg Etoricoxib for one day (Part1) or for two days (Part2) and placebo.
Time frame: within 4 days post dosing (study part 1 and 2)
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School