Pain Post Abdominal Laparoscopy Prevention With Arcoxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565682
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Merck Sharp & Dohme Corp.
Information provided by:
Hospital Vozandez

November 29, 2007
November 30, 2007
November 30, 2007
April 2006
Not Provided
To measure the amount of rescue medication (opioid) needed to relief [ Time Frame: Every hour after surgery ]
Same as current
No Changes Posted
To determine the overall analgesic effect using the visual analog scale (VAS) [ Time Frame: Every hour after surgery ]
Same as current
Not Provided
Not Provided
Pain Post Abdominal Laparoscopy Prevention With Arcoxia
Pain Post Abdominal Laparoscopy Prevention With Arcoxia
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Laparoscopic Surgery for Appendicitis
  • Laparoscopic Surgery for Cholecystitis
  • Laparoscopic Surgery for Ovarian Cysts
Drug: etoricoxib 120 mg
etoricoxib 120 mg, tablet, orally, OD
Other Name: Arcoxia
Experimental: A
Etoricoxib 120 mg
Intervention: Drug: etoricoxib 120 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2006
Not Provided

Inclusion Criteria:

  • Voluntary acceptance to participate in the study and signed the informed consent form
  • Age older than 18 years old and younger than 70 years
  • Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery

Exclusion Criteria:

  • Age less than 18 years or older than 70 years.
  • Laparoscopic procedures for diagnostic purposes.
  • Current use of anticoagulants.
  • Known hypersensitivity to etoricoxib or its components.
  • History of a CABG or MI (less than 1 year)
  • History of unstable angina (over the past six months).
  • Current inflammatory bowel disease.
  • Uncontrolled hypertension or heart failure
  • Renal dysfunction/impairment (creatinine clearance < 30ml/min)
  • Cirrhosis or severe hepatic dysfunction
  • Any degree of dehydration (mild to severe)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Eduardo Noboa, Hospital Vozandez
Hospital Vozandez
Merck Sharp & Dohme Corp.
Principal Investigator: Eduardo Noboa, MD Hospital Vozandez
Hospital Vozandez
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP