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
  Purpose

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.


Condition Intervention Phase
Laparoscopic Surgery for Appendicitis
Laparoscopic Surgery for Cholecystitis
Laparoscopic Surgery for Ovarian Cysts
Drug: etoricoxib 120 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Resource links provided by NLM:


Further study details as provided by Hospital Vozandez:

Primary Outcome Measures:
  • To measure the amount of rescue medication (opioid) needed to relief [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the overall analgesic effect using the visual analog scale (VAS) [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2006
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: A
Etoricoxib 120 mg
Drug: etoricoxib 120 mg
etoricoxib 120 mg, tablet, orally, OD
Other Name: Arcoxia

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565682

Sponsors and Collaborators
Hospital Vozandez
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Eduardo Noboa, MD Hospital Vozandez
  More Information

No publications provided

Responsible Party: Eduardo Noboa, Hospital Vozandez
ClinicalTrials.gov Identifier: NCT00565682     History of Changes
Other Study ID Numbers: DOLAAR
Study First Received: November 29, 2007
Last Updated: November 29, 2007
Health Authority: Ecuador: Public Health Ministry

Additional relevant MeSH terms:
Acalculous Cholecystitis
Appendicitis
Cholecystitis
Ovarian Cysts
Adnexal Diseases
Biliary Tract Diseases
Cecal Diseases
Cysts
Digestive System Diseases
Endocrine System Diseases
Gallbladder Diseases
Gastroenteritis
Gastrointestinal Diseases
Genital Diseases, Female
Gonadal Disorders
Infection
Intestinal Diseases
Intraabdominal Infections
Neoplasms
Ovarian Diseases
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014