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Pain Post Abdominal Laparoscopy Prevention With Arcoxia

NCT ID: NCT00565682

Last Updated: 2007-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Surgery for Appendicitis Laparoscopic Surgery for Cholecystitis Laparoscopic Surgery for Ovarian Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Etoricoxib 120 mg

Group Type EXPERIMENTAL

etoricoxib 120 mg

Intervention Type DRUG

etoricoxib 120 mg, tablet, orally, OD

Interventions

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etoricoxib 120 mg

etoricoxib 120 mg, tablet, orally, OD

Intervention Type DRUG

Other Intervention Names

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Arcoxia

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Hospital Vozandez

OTHER

Sponsor Role lead

Responsible Party

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Hospital Vozandez

Principal Investigators

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Eduardo Noboa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vozandez

Other Identifiers

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DOLAAR

Identifier Type: -

Identifier Source: org_study_id