Dysmenorrhea
Conditions
Brief summary
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).
Interventions
DRUGetoricoxib (MK0663)
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
DRUGComparator: placebo (unspecified)
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
DRUGComparator: naproxen sodium
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
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women 18 years of age or older suffering from painful menstruation
Exclusion criteria
* Women taking medications that are not allowed in the study (such as pain medications, antidepressants, tranquilizers, hypnotics, sedatives, or oral contraceptives). * Women who are pregnant, breast-feeding or within 6 weeks of giving birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles |
Secondary
| Measure | Time frame |
|---|---|
| Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium | 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 | 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 | From randomization through 14 days following the last dose of study medication |
Outcome results
None listed