Dysmenorrhea Clinical Trial
Official title:
A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
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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