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

NCT01462370 | Completed Phase 3 Results

• 1 other identifier: 0663-145
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose

  TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.

  Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

Secondary Outcomes (13)

• Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)

  Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

• Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)

  6 hours

• Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)

  24 hours

• Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose

  Baseline and 6 hours

• Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose

  Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

Study Arms (2)

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen

EXPERIMENTAL

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.

Drug: Etoricoxib; Drug: Ibuprofen; Drug: Placebo to etoricoxib; Drug: Placebo to ibuprofen; Drug: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

EXPERIMENTAL

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.

Drug: Etoricoxib; Drug: Ibuprofen; Drug: Placebo to etoricoxib; Drug: Placebo to ibuprofen; Drug: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg

Interventions

Etoricoxib DRUG

Etoricoxib 120 mg tablet given orally for one dose.

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen; Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

Ibuprofen 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.

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen; Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

Placebo to etoricoxib DRUG

Placebo to etoricoxib, one tablet.

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen; Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

Placebo to ibuprofen DRUG

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

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen; Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

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

Also known as: Saridon

Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen; Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 24960147 RESULT

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Etoricoxib; Ibuprofen; Acetaminophen; Saridon

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: October 31, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 9, 2022
• Results First Posted: July 10, 2013

Record last verified: 2022-02