Pain Post Abdominal Laparoscopy Prevention With Arcoxia

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Hospital Vozandez
ClinicalTrials.gov Identifier:
NCT00565682
First received: November 29, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 29, 2007
November 29, 2007
April 2006
Not Provided
To measure the amount of rescue medication (opioid) needed to relief [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
To determine the overall analgesic effect using the visual analog scale (VAS) [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00565682
DOLAAR
No
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