Phase 3
N=139
Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT01462370 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose — 17.38; 16.49 Score on a Scale — p=0.043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Etoricoxib (Drug); Ibuprofen (Drug); Placebo to etoricoxib (Drug); Placebo to ibuprofen (Drug); Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose |
17.38; 16.49 | 0.043 sig |
| SECONDARY Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6) |
9.48; 9.27 | 0.768 |
| SECONDARY Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6) |
2.50; 2.24 | 0.007 sig |
| SECONDARY Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24) |
2.65; 2.29 | <0.001 sig |
| SECONDARY Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose |
1.0; 1.5 | 0.371 |
| SECONDARY Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose |
2.2; 2.1 | 0.051 |
| SECONDARY Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose |
3.70; 3.52 | 0.019 sig |
| SECONDARY Number of Participants Using Rescue Medication 24 Hours After the Initial Dose |
1; 4 | — |
| SECONDARY PID at Up to 12 Hours Following the Initial Dose |
2.28; 2.07 | <0.001 sig |
| SECONDARY PR at Up to 12 Hours Following the Initial Dose |
3.73; 3.45 | 0.002 sig |
| SECONDARY PID at Up to 24 Hours Following the Initial Dose |
2.36; 2.25 | 0.011 sig |
| SECONDARY PR at Up to 24 Hours Following the Initial Dose |
3.88; 3.62 | 0.004 sig |
| SECONDARY Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose |
111; 103 | 0.112 |
| SECONDARY Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose |
113; 101 | 0.019 sig |
Summary
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.
Eligibility Criteria
Inclusion Criteria
- Agree to remain abstinent or use double-barrier contraception throughout the study. Participants who are status post tubal ligation are exempt from this requirement.
- Moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. Moderate: Over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. Severe: Over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity.
- Willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle.
- Able to read, understand, and complete diary.
Exclusion Criteria
- Use of an intrauterine device. Pregnant, breast feeding, or or equal to 5 years prior to screening. Participants with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment.
- Allergic to etoricoxib, ibuprofen, acetaminophen, indomethacin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclooxygenase (COX)-2 inhibitors, or to components in Saridon (propyphenazone/paracetamol/caffeine).
- Recent history of chronic analgesic or tranquilizer use or dependence.
- Morbidly obese and demonstrates significant health problems stemming from the obesity.
- Current user of recreational or illicit drugs or had a recent history of drug or alcohol abuse or dependence.
- Participated in another clinical study within the last 4 weeks.
- Not able to swallow oral medications: surgical or anatomical conditions that will preclude from swallowing and absorbing oral medications on an ongoing basis.
Data sourced from ClinicalTrials.gov (NCT01462370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.