NCT00565682

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
Last Updated

November 30, 2007

Status Verified

November 1, 2007

First QC Date

November 29, 2007

Last Update Submit

November 29, 2007

Conditions

Laparoscopic Surgery for AppendicitisLaparoscopic Surgery for CholecystitisLaparoscopic Surgery for Ovarian Cysts

Outcome Measures

Primary Outcomes (1)

  • To measure the amount of rescue medication (opioid) needed to relief

    Every hour after surgery

Secondary Outcomes (1)

  • To determine the overall analgesic effect using the visual analog scale (VAS)

    Every hour after surgery

Study Arms (1)

A

EXPERIMENTAL

Etoricoxib 120 mg

Drug: etoricoxib 120 mg

Interventions

etoricoxib 120 mgDRUG

etoricoxib 120 mg, tablet, orally, OD

Also known as: Arcoxia
A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Etoricoxib

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eduardo Noboa, MD

    Hospital Vozandez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

April 1, 2006

Study Completion

December 1, 2006

Last Updated

November 30, 2007

Record last verified: 2007-11