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

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ClinicalTrials.gov Identifier: NCT00092729
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: etoricoxib (MK0663) Drug: Comparator: placebo (unspecified) Drug: Comparator: naproxen sodium Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea
Actual Study Start Date : June 7, 2002
Primary Completion Date : December 6, 2002
Study Completion Date : December 6, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
etoricoxib
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
Other Name: MK0663
Placebo Comparator: 2
Placebo to match etoricoxib
Drug: 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
Active Comparator: 3
naproxen sodium
Drug: 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
Other Name: naproxen sodium


Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: 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 ]
  2. Time to onset, peak, and duration of the analgesic effect compared with placebo [ Time Frame: to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles ]

Secondary Outcome Measures :
  1. Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium [ Time Frame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles ]
  2. Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo [ Time Frame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles ]
  3. Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences [ Time Frame: From randomization through 14 days following the last dose of study medication ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092729


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092729     History of Changes
Other Study ID Numbers: 0663-064
MK0663-064
2004_053
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors