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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00092729
Other study ID # 0663-064
Secondary ID MK0663-0642004_0
Status Completed
Phase Phase 3
First received
Last updated
Start date June 7, 2002
Est. completion date December 6, 2002

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date December 6, 2002
Est. primary completion date December 6, 2002
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
etoricoxib (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
Comparator: 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
Comparator: 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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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