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A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00788710
First received: November 5, 2008
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.


Condition Intervention Phase
Acute Pain Following a Total Abdominal Hysterectomy
 Drug: etoricoxib (MK0663) 120 mg
Drug: Comparator: Placebo
Drug: etoricoxib (MK0663) 90 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Average Pain Intensity at Rest Over Days 1 to 3 [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
    Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.


Secondary Outcome Measures:
  • Average Total Daily Dose of Morphine Over Days 1 to 3 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Average Elicited Pain Upon Sitting Over Days 1 to 3 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.


Enrollment: 430
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etoricoxib 120 mg
etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
 Drug: etoricoxib (MK0663) 120 mg
120 mg of etoricoxib (MK0663) for a total of 5 days
Other Name: Arcoxia
Experimental: Etoricoxib 90 mg
etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
 Drug: etoricoxib (MK0663) 90 mg
90 mg of etoricoxib (MK0663) for a total of 5 days
Placebo Comparator: Placebo
Placebo- 3 tablets once daily
 Drug: Comparator: Placebo
Placebo tablets once daily on Days 1-5. Total treatment is 5 days.

  Eligibility

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

Inclusion Criteria:

  • Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Exclusion Criteria:

  • Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
  • Patient has uncontrolled high blood pressure
  • Patient has a history of drug and/or alcohol abuse within the last 5 years
  • Patient has taken part in another investigational study within 4 weeks of the start of study
  • Patient is breast-feeding
  • Patient has an active ulcer or inflammatory bowel disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788710

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00788710     History of Changes
Other Study ID Numbers: MK-0663-097, 2008_578
Study First Received: November 5, 2008
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013