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

Purpose

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.

Condition	Intervention	Phase
Dysmenorrhea	Drug: Etoricoxib Drug: Ibuprofen Drug: Placebo to etoricoxib Drug: Placebo to ibuprofen	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrhea

Resource links provided by NLM:

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysinate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Total Pain Relief score over the first 6 hours (TOPAR6) after the initial dose in each cycle [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sum of Pain Intensity Difference scores over the 6-hour time period (SPID6) after the initial dose in each cycle [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Participant's Global Evaluation for pain at 6 and 24 hours after the initial dose in each cycle [ Time Frame: 6 hours and 24 hours ] [ Designated as safety issue: No ]
Time to 1 unit improvement from Baseline in pain intensity during the 6 hours after the initial dose in each cycle (time to pain intensity difference [PID] greater than or equal to 1) [ Time Frame: Baseline and 6 hours ] [ Designated as safety issue: No ]
Peak PID during the 6 hours after the initial dose in each cycle [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Peak pain relief (peak PR) during the 6 hours after the initial dose in each cycle [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Time to rescue medication use during the 6 and 24 hours after the initial dose in each cycle [ Time Frame: 6 hours and 24 hours ] [ Designated as safety issue: No ]
PID and PR at 12 and 24 hours after the initial dose in each cycle [ Time Frame: 12 hours and 24 hours ] [ Designated as safety issue: No ]
Number of participants with a global evaluation of study medication of good to excellent at 6 and 24 hours after the initial dose in each cycle [ Time Frame: 6 hours and 24 hours ] [ Designated as safety issue: No ]

Enrollment:	132
Study Start Date:	November 2011
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Etoricoxib Etoricoxib 120 mg tablet given orally for one dose. 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. Drug: Placebo to etoricoxib Placebo to etoricoxib, one tablet. Drug: Placebo to ibuprofen Placebo to ibuprofen, up to four 3-capsule doses.
Experimental: 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.	Drug: Etoricoxib Etoricoxib 120 mg tablet given orally for one dose. 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. Drug: Placebo to etoricoxib Placebo to etoricoxib, one tablet. Drug: Placebo to ibuprofen Placebo to ibuprofen, up to four 3-capsule doses.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01462370 History of Changes
Other Study ID Numbers:	MK-0663-145
Study First Received:	October 27, 2011
Last Updated:	August 9, 2012
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:

Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Ibuprofen
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013