An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)

Dysmenorrhea Clinical Trial

Official title:

A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea

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
• 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
• 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

Related Conditions & MeSH terms

• Dysmenorrhea

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