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OpenTrials
Completed

NCT Number: NCT00788710

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

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.

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Key information

Conditions

Acute Pain Following a Total Abdominal Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etoricoxib (MK0663) 120 mg

Drug

120 mg of etoricoxib (MK0663) for a total of 5 days

Other names: Arcoxia

Comparator: placebo

Drug

Placebo tablets once daily on Days 1-5. Total treatment is 5 days.

etoricoxib (MK0663) 90 mg

Drug

90 mg of etoricoxib (MK0663) for a total of 5 days

Primary outcomes

  1. Average Pain Intensity at Rest Over Days 1 to 3

    Time frame: 3 Days

    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 outcomes

  1. Average Total Daily Dose of Morphine Over Days 1 to 3

    Time frame: 3 days

  2. Average Elicited Pain Upon Sitting Over Days 1 to 3

    Time frame: 3 days

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 11, 2008
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.