An Investigational Drug Study in the Treatment of Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092729
First received: September 23, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Dysmenorrhea
Drug: etoricoxib (MK0663)
Drug: Comparator: placebo (unspecified)
Drug: Comparator: naproxen sodium
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 Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: June 2002
Study Completion Date: December 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092729

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092729     History of Changes
Other Study ID Numbers: 2004_053, MK0663-064
Study First Received: September 23, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014