Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)

NCT ID: NCT01462370

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-06-30

Brief 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.

Detailed Description

Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles.

In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.

Conditions

Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen

Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.

Group Type: EXPERIMENTAL

Etoricoxib

Intervention Type: DRUG

Etoricoxib 120 mg tablet given orally for one dose.

Ibuprofen

Intervention Type: DRUG

Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.

Placebo to etoricoxib

Intervention Type: DRUG

Placebo to etoricoxib, one tablet.

Placebo to ibuprofen

Intervention Type: DRUG

Placebo to ibuprofen, up to four 3-capsule doses.

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Intervention Type: DRUG

Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.

Group Type: EXPERIMENTAL

Etoricoxib

Intervention Type: DRUG

Etoricoxib 120 mg tablet given orally for one dose.

Ibuprofen

Intervention Type: DRUG

Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.

Placebo to etoricoxib

Intervention Type: DRUG

Placebo to etoricoxib, one tablet.

Placebo to ibuprofen

Intervention Type: DRUG

Placebo to ibuprofen, up to four 3-capsule doses.

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Intervention Type: DRUG

Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

Interventions

Etoricoxib

Etoricoxib 120 mg tablet given orally for one dose.

Intervention Type: DRUG

Ibuprofen

Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.

Intervention Type: DRUG

Placebo to etoricoxib

Placebo to etoricoxib, one tablet.

Intervention Type: DRUG

Placebo to ibuprofen

Placebo to ibuprofen, up to four 3-capsule doses.

Intervention Type: DRUG

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

Intervention Type: DRUG

Other Intervention Names

Saridon

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 <6 weeks postpartum.
• Active gastric ulcer or history of inflammatory bowel disease.
• Uncontrolled hypertension.
• Uncontrolled diabetes mellitus or renal disease.
• Class II-IV congestive heart failure.
• Coronary artery bypass graft surgery, angioplasty, myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
• Unstable angina.
• Mild, moderate, or severe hepatic insufficiency.
• Any personal or family history of an inherited or acquired bleeding disorder.
• History of neoplastic disease; Exceptions: 1)adequately treated basal cell carcinoma or carcinoma in situ of the cervix; 2) other malignancies which have been successfully treated > 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Yu Q, Zhu X, Zhang X, Zhang Y, Li X, Hua Q, Chang Q, Zou Q, Di W, Yao Y, Yu W, Liu J, Mehta A, Yan L. Etoricoxib in the treatment of primary dysmenorrhea in Chinese patients: a randomized controlled trial. Curr Med Res Opin. 2014 Sep;30(9):1863-70. doi: 10.1185/03007995.2014.925437. Epub 2014 Jun 30.

Reference Type: RESULT

PMID: 24960147 (View on PubMed)

Other Identifiers

0663-145

Identifier Type: -

Identifier Source: org_study_id