A Phase 3 interventional study of etoricoxib (MK0663) and Comparator: placebo (unspecified) in Dysmenorrhea, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's enrollment of 129 is above the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
etoricoxib
Drug: etoricoxib (MK0663)
Placebo to match etoricoxib
Drug: Comparator: placebo (unspecified)
naproxen sodium
Drug: Comparator: naproxen sodium
Two etoricoxib 60 mg tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
Also known as: MK0663
Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea
Also known as: naproxen sodium
Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo
Time frame: Up to 8 hours postdose and at 8 and 24 hours postdose, following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Time to onset, peak, and duration of the analgesic effect compared with placebo
Time frame: to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium
Time frame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo
Time frame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences
Time frame: From randomization through 14 days following the last dose of study medication
No study locations are listed for this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Organon and Co