A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery

June 8, 2009 updated by: Pfizer

A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery

The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Port Macquarie, New South Wales, Australia
        • Pfizer Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • Queensland
      • Coopers Plain, Queensland, Australia, 4108
        • Pfizer Investigational Site
      • Townsville, Queensland, Australia, 4814
        • Pfizer Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
      • Prahran, Victoria, Australia, 3181
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6847
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
  • American Society of Anaesthesiologists (ASA) Physical Status I-III

Exclusion Criteria:

  • Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
  • Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
Placebo Comparator: Group 2
A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of unplanned hospital admissions on Day 4.
Time Frame: 4 days
4 days
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
Time Frame: 4 days
4 days
Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.
Time Frame: 4 days
4 days
Length of stay on Day 1.
Time Frame: 1 day
1 day
Patient Satisfaction Questionnaire on Days 1 and 4.
Time Frame: 4 days
4 days
Quality of Recovery Score on Days 1, 2, and 3.
Time Frame: 3 days
3 days
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
Time Frame: 4 days
4 days
Modified Brief Pain Inventory on Days 2, 3, and 4.
Time Frame: 4 days
4 days
Readiness for discharge on Day 1.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 8, 2009

Last Verified

June 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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